Apparatus and method for everting catheter for iud delivery and placement in the uterine cavity

ABSTRACT

An everting balloon system is disclosed that can be used for the placement of an IUD within the uterine cavity of a female patient. The everting balloon system with IUD can be used to access a uterine cavity at specific locations in the fundus. A one-handed IUD delivery system for placement with an everting catheter is disclosed. An IUD loading system for placement within an everting catheter is disclosed. The everting catheter with an IUD can simplify the process of IUD placement within the uterine cavity.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. application Ser.No. 17/067,352, filed Oct. 9, 2020, which claims priority to U.S.Provisional Application No. 62/913,160, filed Oct. 9, 2019, both ofwhich are incorporated by reference herein in their entireties.

BACKGROUND

The apparatuses and methods disclosed herein can have utility foreverting catheters that are characterized with an inner catheter, outercatheter, and everting membrane that can be connected to both catheters.The inner catheter may contain an inner lumen to pass fluid or media,drugs or therapeutic agents, instruments or devices such as intrauterineuterine devices (IUDs), endoscopes, and other catheters.

For physicians and medical professionals, accessing systems for vesselsand bodily cavities in patients have typically used various guidewireand catheter technologies. In some cases, the process requires theinsertion of a series of mandrels or wires to increase the lumendiameter for the eventual passage of a larger bore instrument within thevessel. This technique can be referred to as “Dottering” or in the caseof accessing the cervical canal and uterus, physicians will use a seriesof increasing diameter mandrels known as Hegar dilators. In thetechniques described above, the methods involved pushing an object,mandrel, or device through the vessel to gain access to a desired regionin the body. The result of pushing an object, mandrel, or device createsshear forces on the lumen wall. In some cases, the shear forces canresult in trauma, pain for the patient, or perforation.

In contrast, another access technology that has been used in prior artis referred to as an everting catheter. Everting catheters utilize atraversing action in which a balloon is inverted and with the influenceof hydraulic pressure created by a compressible or incompressible fluidor media, rolls inside out or everts with a propulsion force through thevessel. Everting balloons have been referred to as rolling or outrollingballoons, evaginating membranes, toposcopic catheters, or lineareverting catheters such as those in U.S. Pat. Nos. 5,364,345; 5,372,247;5,458,573; 5,472,419; 5,630,797; 5,902,286; 5,993,427; 6,039,721;3,421,509; and 3,911,927; all of which are incorporated herein byreference in their entireties. These are categorized as evertingballoons and are for traversing vessels, cavities, tubes, or ducts in africtionless manner. In other words, an everting balloon can traverse atube without imparting any shear forces on the wall being traversed.Because of this action and lack of shear forces, resultant trauma can bereduced and the risk of perforation reduced. In addition, as a result ofthe mechanism of travel through a vessel, material and substances in theproximal portion of the tube or vessel are not pushed or advancedforward to a more distal portion of the tube or vessel.

In addition, as the everting catheter deploys inside out, uncontaminatedor untouched balloon material is placed inside the vessel wall. In theinverted or undeployed state, the balloon and the IUD are housed insidethe catheter body and cannot come into contact with the patient orphysician. As the balloon is pressurized and everted, the balloonmaterial rolls inside out without contacting any element at the entranceoutside of the vessel. For the delivery of IUDs, the action of theballoon material rolling inside out also prevents the IUD to contact anyelement at the vaginal wall, exocervix, endocervical canal, anddepending upon the depth of insertion, the internal cervical os of thepatient. Another advantage of an everting balloon catheter is that themethod of access is more comfortable for the patient since the hydraulicforces “pull” the balloon membrane through the vessel or duct as opposedto a standard catheter that needs to be “pushed” into and through thevessel or duct. For the delivery of IUDs, the hydraulic forces “pull”the balloon membrane and IUD through the cervix and into the uterinecavity as opposed to a standard IUD catheter tube that needs to be“pushed” into and through the cervix and into the uterine cavity.

For access to the uterine cavity with larger devices, the methodtypically used by physicians for accessing the cervical canal in womenrequires the use of multiple instruments of increasing diameter. Thephysician will use a small uterine sound or small diameter probe orHegar device for gaining initial entry into the uterus via the cervix.Ever increasing sizes of Hegars are used to stretch the cervical musclesuntil the desired internal diameter is achieved for the insertion of asecondary instrument such as an endoscope or other device. This processcan be particularly difficult in some nulliparous women who are seekingcontraception with an IUD or women elect to use a hormonal IUD foralleviating abnormal bleeding. Post-menopausal women can also presentwith very small diameter cervical canals. A cervix could be difficult totraverse as a result of prior surgery, underlying stenosis, or otheranatomical configuration or tortuosity that makes the passage ofinstruments or Hegar dilators difficult.

There are some cervical dilators that provide radial expansion to openthe cervical canal to a greater internal diameter without the insertionof multiple instruments. All of these devices are predicated on firstcrossing or traversing the cervical canal prior to the step of radialexpansion. Once traversed through the cervical canal, these devices useeither mechanical means or the expansion of a balloon dilation memberthat is concentric on the exterior of the dilator probe. If the cervicalcanal is particularly tight or narrow, a small diameter probe or mandrelmay be required to first cross the cervix and access the uterine cavity.As mandrels or instruments get smaller in diameter, the likelihood ofperforation or a false passage increases. In any case, these cervicaldilators require passage or crossing by the initial probe prior to anyfurther radial expansion being performed.

Everting catheters have been described as dilatation catheters.Representative examples of dilating everting catheters include U.S. Pat.Nos. 5,364,345 and 4,863,440, both of which are incorporated byreference herein in their entireties.

Everting catheters have also been described with additional elementssuch as a handle for controlling instruments within an evertingcatheter. A representative example is U.S. Pat. No. 5,346,498 which isincorporated by reference herein in its entirety. Everting ballooncatheters can be constructed with an inner catheter with an internallumen or through-lumen (or thru-lumen). The through-lumen can be usedfor the passage of instruments, media, materials, therapeutic agents,endoscope, guidewires, or other instruments or devices. Representativesamples of everting catheters with through-lumens are in U.S. Pat. Nos.5,374,247 and 5,458,573. In addition, everting catheters have beendescribed with waists or a narrowing of the balloon diameter, such as inU.S. Pat. No. 5,074,845, which is incorporated by reference herein inits entirety.

Everting catheters are particularly useful for accessing the uterinecavity where the endocervical canal may be stenotic, tortuous, orcontain the presence of a C-section scar or other anatomicalconfiguration that makes the passage of instruments difficult for thephysician. This in turn can lead to an uncomfortable procedure for thepatient.

One common gynecological procedure is the placement of IUDs for womenwho are either seeking a non-permanent method of birth control ormedication from an intrauterine device that elutes hormonal treatmentfor abnormal uterine bleeding, painful periods, or other medicationsthat may be placed by an implant in the uterine cavity. IUDs can containcopper and can be configured in numerous configurations. In all of thesecases, the physician needs to place the device within the uterinecavity.

For the placement of IUDs in the uterus, IUD inserters consist of fairlystiff tubes or cannula for insertion. The IUD implant itself can beconfigured in a “T-shape” or “Y-shape” in its natural, uncollapsed statein which the three arms of the “T” or “Y” are constructed as rigidmembers that can flex, but are not easily bent in a tight radius lessthan 0.500″. The “T” or “Y” configuration is needed to maintain the IUDwithin the uterine cavity during the normal activities of the woman andotherwise more forceful activities such as exercise, coughing, and theuterine contractions that occur with menses. In these situations, the“T” or “Y” shape is needed to prevent expulsion or migration from theuterine cavity since the arms of the “T” or “Y” are designed to keep theIUD near the patient's fundus with its rounded ends approximating thebilateral cornua of the uterine cavity. Not all IUDs are “T” or “Y”shaped and other configurations including circular or coiled shaped areknown or available commercially.

In clinical use during device placement, the endocervix may havemultiple turns and curvatures that contain tight radii curves. Forplacement through the endocervix and to straighten the cervical canal toreduce the amount of curvature, the physician needs to grasp the cervixand maintain counter-traction on the cervix. Besides straightening thecervix, the counter-traction facilitates pushing the IUD inserterthrough the endocervical canal and into the uterine cavity.Misplacements, perforations, or the inability to place the IUD, are allknown and recognized outcomes or adverse events with an IUD placementprocedure. The stiffness of the cannula and the IUD implant itself alsoleads to patient discomfort during the placement procedure. This isparticularly true for women who have stenotic cervices or who arenulliparous.

Once the IUD is in the proper position in the patient, the IUD insertercan have a cannula that is attached to a handle that allows thephysician to translate the IUD from out of the distal end of thecannula. The handle allows the physician to perform the placementprocedure with one hand.

Following the placement of the IUD in the uterine cavity, the IUDinserter is withdrawn from the patient. The retrieval suture or suturesof the IUD remains in the patient's endocervical canal when sliding theinserter out of the cervix. Once removed, the physician can trim thevisible sutures extending from the exocervix. The IUD sutures arevisible in the patient's vagina emanating from the exocervix and can betrimmed to length as indicated by the IUD manufacturer's labeling.

Also, when delivering an IUD, instruments, devise, and reproductivematerial such as an embryo, into the uterine cavity, the access systemcan push cervical mucus or fluids and materials from the vagina into theuterine cavity. There is a potential that these fluids and materialsfrom the vagina could promote bacterial infection. The action of theunrolling balloon is designed to minimize this effect.

In addition, access systems for the uterine cavity can create a vacuumeffect when the access system is being withdrawn or removed from theuterine cavity. This vacuum effect can unintentionally remove thereproductive material from the uterine cavity in the situation of embryotransfer. In existing systems, when the transfer catheter is retractedfrom a second outer or guiding catheter (e.g., the “inner” catheter),the retraction produces vacuum pressure within the uterine cavity. Thisvacuum pressure is created in the uterine cavity by the removal andbackward movement of the transfer catheter within the inner catheter.After the embryo transfer is completed, an embryologist may inspect thetransfer catheter to verify that the embryos or reproductive materialwas indeed deposited in the uterus and not pulled back into the transfercatheter because of the vacuum effect. The same procedure may be donefor the outer catheter once this catheter is removed. For IUD placement,having a system that can potentially reduce vacuum effect can lead tomore reliable and exact IUD placement.

Further, everting balloons describe an action in which a balloon isinverted and, with the influence of hydraulic pressure created by acompressible or incompressible fluid or media, rolls inside out oreverts with that propulsion force. Everting balloons have been referredto as rolling or outrolling balloons, evaginating membranes, toposcopiccatheters, or linear everting balloons. These are all categorized aseverting balloons due to their property of traversing vessels, cavities,tubes, or ducts in a substantially frictionless manner. Evertingballoons can traverse a tube without imparting any significant shearforces on the wall being traversed. Because of this action and lack ofshear forces, material and substances in the proximal portion of thetube or vessel are pushed or advanced forward to a more distal portionof the tube or vessel. For example for 1 everting balloons in the femalereproductive tract, potentially infectious substances from the vagina,cervical os or exocervix, or the legs or other anatomy of the patient,and the hands of the physician during insertion or catheter preparation,are not in contact with the everted balloon that resides in the cathetersystem prior to deployment in the patient. The objective of keeping theeverting balloon isolated from potentially uncleanly surfaces is toreduce post-procedural infections.

SUMMARY OF THE INVENTION

An everting balloon system is disclosed. The everting balloon system canbe used for IUD placement, delivery of instruments, devices, andendoscopes, and insemination, urinary incontinence, dilation of a bodylumen, for access and sealing within a body cavity, or combinationsthereof. The system can have automatic deployment and disengagement. Thesystem can have a handle for insertion. The system can have a motorizedair or fluid pump or pressurization source. The system can have innerand outer catheters that can automatically disengage upon everting.

The everting balloon system can have an intubating base with a lockingballoon that can activate upon pressurization. The system can be acompact, low profile unit used in vivo. The system can be single use anddisposable. The system can be non-irritation and non-infection causing.

The everting balloon system can be used for cervical access, dilation,and the delivery of IUDs. The everting balloon system can have a systemhandle mechanism that can enable a one-handed operating technique by theuser. The one-handed operating technique can include advancement andpressurization of the everting balloon membrane within the control ofthe user with one hand.

The everting balloon system can be used for the insertion of drugdelivery devices, or insemination, and can seal the cervix for aduration of time for the deposition of drug agent or sperm and to allowfor mobility for the patient. The everting balloon system can have adecoupling mechanism configured to decouple the outer catheter and innercatheter while maintaining hydraulic pressure in an everting balloon.The system can deflate and removal the everting balloon concurrently.

The system can be used to place or deliver fallopian tube inserts (i.e.,intratubal inserts, such as the Essure device from Bayer Corporation) infallopian tubes. The system can access the intramural and isthmicportions of the fallopian tube. All or part of the everting cathetersystem can be loaded into a hysteroscope and placed with directendoscopic visualization.

The everting catheter system can be a selective fallopian tube catheterwith a curved distal end section and angled ball tip. This configurationcan be performed by ultrasound or radiographic visualization.

One or more fallopian tube occluding devices (e.g., the Essure device)can be loaded into the everting balloon system, for example, in thethrough lumen of the inner catheter. Once fully everted and placed intothe fallopian tube, the everting balloon system, such as the innercatheter, can be withdrawn from the fallopian tube while leaving thefallopian tube occluding device in the fallopian tube. Once the evertingballoon system is withdrawn from the fallopian tube, the fallopian tubeoccluding can be deployed (e.g., device anchors such as coils can beextended, or a resilient porous matrix can expand to friction fit thetube lumen). Once the fallopian tube occluding device is deployed, acentral guidewire can be removed from the fallopian tube. The procedurecan be repeated for the contralateral fallopian tube.

The everting balloon system can be used to access the bladder, ureters,kidneys, or combinations thereof. Devices, tools, instrumentation,endoscopes, drugs, therapeutic agents, sampling devices (brushes,biopsy, and aspiration mechanisms), or combinations thereof can bedelivered through the inner catheter lumen to the target site.

Specialized everting catheter systems with specific instruments, tools,or functions built or placed within the everting catheter system arealso disclosed herein. Examples of such tools or instruments are biopsydevices, cytology devices, drug delivery mechanisms, fluid deliverymechanisms, endoscopes, IUDs, or other tools to be delivered into abodily cavity, a bodily space, a potential bodily space that is createdby the everting balloon mechanism, or a bodily vessel. There are severaladvantages to having an IUD built or placed into the everting cathetersystem as the delivery mechanism. The everting balloon can be used topull the IUD implant into the uterine cavity without requiring thephysician or operator to push an inserter through the endocervix andinto the uterine cavity. This is particularly useful for tortuous ortight cervices. In addition, the everting membrane rolls inside-outthrough passageways in a frictionless manner without imparting shearforces on the inner lumen wall. The everting balloon works to protectthe body passageway from the distal end profile of the IUD while pullingthe IUD into the desired location.

The IUD can be fixed to the everting catheter system and automaticallyextends beyond the distal end of the everting balloon by being pulled bythe everting balloon into the uterine cavity. During the eversionprocess, the IUD can be shielded from the body tissue until it extendsbeyond the distal end of the everting balloon. In this process the IUDwill not contact the vagina, exocervix, or other fluids, mucus, ortissue in the proximal region of the endocervix. Providing the IUD at aspecific distance in the everting catheter system can provide thephysician the ability to direct the IUD to an exact distance from theexocervix or specific location in the uterine cavity.

An IUD placement procedure can be performed or delivered in particularlocations in the uterine cavity.

An everting membrane for IUD placement can be designed for one-handedplacement.

An everting membrane for IUD placement can be designed for one-handedplacement with automatic negative pressure during the release of theIUD.

An everting membrane for IUD placement can be designed for one-handedplacement with automatic or manual irrigation through the central lumenduring the release of the IUD. The automatic irrigation can facilitatedevice placement by releasing the IUD from the everting membrane.Irrigation through the central lumen prior to loading the IUD within aneverting catheter, or the delivery and release of the IUD in theeverting membrane, by increasing the lubricity or the IUD within theeverting membrane so that the IUD can slide out of the everting membranewith reduced friction. Equipping the everting catheter for IUD deliveryand placement with an irrigation function is especially useful sincesome IUDs contain hormonal drugs, coatings, or other therapeutic agentsthat can be tacky when interacting against the surface of certainpolymers that are useful in catheter fabrication.

The irrigation mechanism, whether done automatically or manually, can beused to facilitate device visualization in the uterine cavity usingultrasonography, fluoroscopy, or direct visualization with an endoscopethrough the central lumen of the IUD inserter. The injection of salineas an example with the irrigation mechanism through the central lumencan provide the physician a slightly distended uterine cavity in whichultrasonographic visualization of the IUD in the uterine cavity forconfirmation of IUD placement.

The IUD system can have a transfer mechanism to facilitate the loadingof commercially available or second party IUDs in the everting catheter.Once loaded with the IUD, the everting catheter is ready for placementinto the patient's uterus. The transfer mechanism includes a loadingapparatus of retrograde loading the second-party IUD into the distal endof everting membrane and a snare for capturing and retracting the IUDsutures through the central lumen of the everting catheter. The entiremechanism is contained within a flat stand that will fit on a standardprocedure prep table. In operation, the loading mechanism can facilitateloading of a second party IUD within an everting catheter prior todelivery into a patient.

An everting catheter system for an IUD placement procedure can be afacilitated by an aspiration system for holding onto the device duringthe initial steps of device loading. The aspiration system can work inconjunction with the distal end opening of a pusher through the centrallumen of the everting catheter to stabilize and pull the IUD intoposition with the everting membrane of the everting catheter system.

An everting catheter system for an IUD placement procedure can utilize atranslatable outer catheter with telescoping sections that providesselected insertion depths within the uterine cavity for IUD deviceplacement. Telescoping sections in the outer catheter can independentlychange and select the insertion depth of the IUD placement withoutaltering any other component of the everting catheter system.

The distal end of the everting membrane at the location of the IUD canhave an echogenic marker for increased ultrasound contrast, visibility,and detection within the patient's uterus or enhanced real timevisualization of IUD placement.

An IUD loading system can allow the user to load a separately suppliedIUD into an everting catheter system. The loading system can include acradle, split tube, and tray fixture to facilitate IUD loading into theeverting catheter system.

Another embodiment uses a derivation of the loading system within themanufacturing process during the construction of an integrated evertingsystem with a pre-loaded IUD.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A through 1E are longitudinal cross-sectional views of the distalend of a variation of a method for using the everting balloon system.

FIG. 2A illustrates a variation of the everting balloon system in afully everted configuration.

FIG. 2B is a cross-sectional view of a variation of the system handle.

FIG. 3A illustrates a variation of the distal end of the evertingballoon system with the dilating balloon in a less than fully inflatedconfiguration.

FIG. 3B illustrates a variation of the distal end of the evertingballoon system with the dilating balloon in a fully inflatedconfiguration.

FIG. 4A illustrates a variation of the everting balloon system with asyringe in an attached, but not yet deployable configuration.

FIG. 4B illustrates a variation of the everting balloon system with thesyringe in an attached and deployable configuration.

FIG. 4C illustrates a variation of the everting balloon system of FIG.4B with the plunger driver shown in cut-away.

FIG. 5A illustrates a length of a variation of the everting balloonsystem.

FIG. 5B is a partial cross-sectional view of a variation of the systemof FIG. 5A.

FIGS. 5C and 5D are variations of side and perspective views of aportion of cross-section A-A.

FIG. 5E is an exploded view of a variation of a portion of the systemhandle and the drive gears.

FIG. 5F is a close-up view of a variation of the system handle at theratchet handle axle.

FIG. 6A is a cross-sectional view of a variation of the system handle.

FIGS. 6B through 6D are side, top perspective and cross-sectional views,respectively, of a variation of the everting balloon system with thesystem handle of FIG. 6A.

FIGS. 7A and 7B are exploded and perspective views, respectively, of avariation of the everting balloon system.

FIG. 8A is a cross-section view of a variation of the three-wayconnector and adjacent elements in a configuration to deliver mediapressure to the outer catheter, for example to the everting balloon.

FIG. 8B is a cross-section view of a variation of the three-wayconnector and adjacent elements in a configuration to deliver mediapressure to the inner catheter, for example to the dilating balloon.

FIG. 9 is an exploded view of a variation of a transfer catheter.

FIGS. 10A through 10C illustrate a variation of method for deliveringmaterial to a target site, such as reproductive material delivered to auterine cavity.

FIGS. 11A through 11C illustrate a variation of a method for deliveringmaterial to a target site, such as reproductive material delivered to auterine cavity.

FIGS. 12A to 12E illustrate an everting catheter for performing an IUDplacement procedure with an everting membrane.

FIGS. 13A to 13I illustrate in both side views and top views additionalderivations built into the distal end of the everting membrane and innercatheter.

FIGS. 14A through 14D illustrate further embodiments demonstrating theadvancement and release of an IUD within an everting membrane.

FIGS. 15A through 15D illustrate an automatic one-handed eversionmechanism for IUD placement.

FIGS. 16A to 16J illustrate a variation of an everting catheter that candeliver an IUD within the uterine cavity.

FIGS. 17A to 17I illustrate a variation of an everting catheter that candeliver an IUD within the uterine cavity.

FIGS. 18A to 18C illustrate mechanisms for automatically providingnegative pressure during the IUD release step of the delivery process.In addition, irrigation through the central lumen can be providedseparately or in conjunction with negative pressure to facilitate theIUD release step.

FIG. 19A illustrates an everting catheter system for delivering an IUD.

FIGS. 19B to 19D are close-up views of the everting catheter system.

FIG. 20A illustrates the everting catheter system after full eversion ofthe balloon in the process of delivering an IUD.

FIG. 20B is a close up view of the distal end of the everted balloon andIUD.

FIG. 20C is a close up view of the proximal portion of the evertingcatheter system after full eversion in the process of delivering an IUD.

FIGS. 21A to 21C illustrate the process of delivering an IUD within asimulated uterine cavity model.

FIGS. 22A to 22E illustrate a packaging configuration for the transitand loading of the everting catheter system for delivering an IUD.

DETAILED DESCRIPTION

An everting balloon system 2 (also referred to as an everting cathetersystem) that can be used to traverse a vessel, such as the cervicalcanal is disclosed. The everting balloon system 2 can be used to accessthe uterine cavity via the cervix. The cervical canal is a single lumenvessel that can stretch or dilate. The everting balloon system 2 canhave a control system that can be operated with one hand. The evertingcatheter system can also traverse other locations in the body of apatient or animal for the purposes of placement of a device within abodily cavity or lumen.

FIGS. 1A through 1E illustrate that an everting catheter system 2 canhave a radially outer catheter 4, a balloon membrane 6, and a radiallyinner catheter 8. The inner catheter 8 can have an inner catheter lumen10 (e.g., a through-lumen). The distal end of the inner catheter lumen10 can be open or closed. The inner catheter 8 can have the innercatheter lumen 10 or be a solid rod or flexible mandrel. The evertingballoon system 2 can have a media volume 12. The media volume 12 can bethe contiguous open volume between the inner catheter 8 and outercatheter 4 that is proximal to the balloon membrane 6. A radially outerterminal perimeter of the balloon membrane 6 can be attached to thedistal terminal end of the outer catheter 4. A radially inner terminalperimeter of the balloon membrane 6 can be attached to the distalterminal end of the inner catheter 8. The everting balloon system 2 canbe made without an inner catheter 8, for example with the balloonmembrane 6 extending proximally out of the working area to a controldevice (e.g., a pump).

FIG. 1A illustrates that the everting catheter system 2 can be in anunpressurized configuration. The media volume 12 can be uninflated andunpressurized. The balloon membrane 6 can be slack.

FIG. 1B illustrates that that everting catheter system 2 can be in apressurized and uneverted configuration. A pressurization device, suchas a pump, for example at the proximal end of the everting cathetersystem 2 can be in fluid communication with the media volume 12. Thepressurization device can deliver a fluid media, such as a pneumatic gasor hydraulic liquid media (e.g., saline, water, air, carbon dioxide, orcombinations thereof), at a media pressure 14 to the media volume 12.The media pressure 14 in the everting balloon 2 can be from about 2 toabout 5 atmospheres of pressure when in the everted configuration andhigher media pressures 14 from about 5 atmospheres to 10 atmospheres arepossible, for example, to provide greater everting capability for moredifficult or stenotic passageways in the body.

The balloon membrane 6 can inflate and be in tension. The balloonmembrane 6 can block the distal port of the inner catheter lumen 10.

FIG. 1C illustrates that the everting catheter system can be in aninflated and partially everted configuration. The inner catheter 8 canbe translated distally, as shown by arrow 16, with respect to the outercatheter 4, and out of the outer catheter 4. The distal terminal end ofthe inner catheter 8 can be proximal of the distal terminal end of theballoon membrane 6. The distal terminal end of the inner catheter 8 canbe proximal or terminal of the distal terminal end of the outer catheter4. The balloon membrane 6 can block the distal port of the innercatheter lumen 10 or can be open allowing fluid communication betweenthe inner catheter lumen 10 and the target site.

FIG. 1D illustrates that the everting catheter system can be in aninflated, fully everted, and fully distally extended configuration. Theinner catheter 8 can be translated distally, as shown by arrow 16, withrespect to the outer catheter 4 until the distal terminal end of theinner catheter 8 is longitudinally beyond or co-terminal with the distalterminal end of the balloon membrane 6. The distal port of the innercatheter lumen 10 can be unobstructedly accessible and in fluidcommunication with the target site.

In the fully inflated configuration, the balloon membrane 6 can form aninflated everting balloon 18. The everting balloon 18 can have a balloonouter diameter 20 and balloon length 22 in the inflated and fullyeverted configuration.

The balloon outer diameter 20 can be from about 2 mm to about 20 mm,more narrowly from about 2 mm to about 7 mm, for example about 5 mm. Theouter diameter can be constant or vary along the length of the evertingballoon 18. For example, for use in the cervical canal, the mostproximal portion of the everting balloon outer diameter 20 could beconfigured with a smaller outer diameter than the remainder of theeverting balloon membrane 24. As an example, the first proximal portionof the everting balloon 18 can have a smaller balloon outer diameter 20such as from about 2 mm to 4 mm for a length of from about 5 mm to about10 mm from the distal terminal end of the outer catheter 4, and theremainder of the length (e.g., from about 4 cm to about 7 cm along theeverting balloon 18) of the everting balloon 18 can have a balloon outerdiameter 20 from about 4 mm to about 7 mm. The outer diameter of theproximal end of the everting balloon 18 can have a consistent balloonouter diameter 20, for example for delivery in the cervix or urethra, offrom about 3 mm to about 6 mm, and the distal-most outer about 2 cm toabout 3 cm of the everting balloon 18 can have a balloon outer diameter20 from about 10 mm to about 20 mm, for example to create a seal withand anchor in the internal cervical os of the uterine cavity or thebladder.

The exterior surface of the balloon membrane 6 can be configured withridges, projections, bumps, grooves, and additional surface ormechanical features, or combinations thereof, for example for increasedfriction or holding power within the vessel, or the entrapment of bodilyfluids, cells, or tissue.

The everting balloon length 22 can be from about 2 cm to about 31 cm,more narrowly from about 2 cm to about 25 cm (e.g., for use in a maleurethra), yet more narrowly from about 2 cm to about 12 cm for placementof IUDs, yet more narrowly from about 3 cm to about 6 cm for invitrofertilization, insemination procedures, or the delivery of instrumentsand endoscopes, for example about 4 cm, about 7 cm, about 15 cm andabout 30 cm.

FIG. 1E illustrates that the everting catheter system can be in aninflated and partially or fully everted configuration. A device or tool26, liquid, gas, or combinations thereof can be translated, as shown bythe arrow 28, through the inner catheter lumen 10, out of the distalport of the inner catheter lumen 10 and into the target site. The tool26 can be an IUD, a biopsy tool, a scope, a sonogram probe, a plug, acauterization tool, or combinations thereof. Suction can be applied fromthe proximal end of the inner catheter lumen 10, and to the target site,for example removing debris from the target site through the innercatheter lumen 10.

To retract and reposition or remove the balloon membrane 6, the innercatheter 8 can be pulled proximally to pull the balloon membrane 6 backwithin the outer catheter 4. The balloon membrane 6 can be deflated orhave media pressure 14 reduced and the entire system can be withdrawnfrom the target site.

FIG. 2 illustrates that the everting balloon system 2 can have a systemhandle 30. The system handle 30 can have a system handle connector 32.The system handle 30 can be attached to the outer catheter 4 and theinner catheter 8, for example at the system handle connector 32. Thesystem handle connector 32 can be removably attached to the outercatheter 4. For example, the outer and inner catheters 4, 8 and balloonscan be detached from the system handle 30 and replaced. The systemhandle 30 can be sterilizable. Media (e.g., liquid or gas) delivered bythe system handle 30 can be filled into the system handle 30 beforeattaching or replacing the catheters and balloons.

The system handle 30 can have a rigid system handle case 34 and a rigidpump lever 36 rotatably attached to the system handle 30 case at a pumplever axle 38.

The system handle 30 can have an inlet port 40. The everting balloonsystem 2 can have a pressurization source. The pressurization source canhave a flexible liquid reservoir 42 or fluid supply container or bag.The fluid bag can be filled with a hydraulic and/or pneumatic fluid. Theinlet port 40 can be a female luer fitting and connection. The inletport 40 can be in fluid communication through an inlet-reservoir channel44 with the flexible reservoir 42. The liquid reservoir 42 can bebetween the rigid pump lever 36 and a rigid system handle case 34. Theinlet port 40 can extend out of the proximal end of the system handlecase 34. The inlet port 40 can be configured to attach to a liquidsource (e.g., a hose, tube, or supplemental reservoir configured todeliver the liquid through the inlet port 40 and to the liquid reservoir42). The inlet port 40 can have a proximal check valve or one-way valveconfigured to allow flow to the liquid reservoir 42 and prevent backflow(e.g., proximal flow from the liquid reservoir 42 and out the inlet port40).

The liquid reservoir 40 can be in one-way (e.g., via a check valve) ortwo-way fluid communication with the media volume 12.

When the liquid reservoir 42 contains liquid, the pump lever 36 canrotate away from the system handle case 34, as shown by pump leverrotation arrows 46, as the liquid reservoir 42 inflates. The pump lever36 can be rotated toward the system handle case 34 to compress theliquid reservoir 42, for example, forcing liquid from the liquidreservoir 42 and into the media volume 12 of the everting balloon 18.

The pump lever 36 can provide a pumping (e.g., suction) action to supplyaspiration to withdraw liquid from the media volume 12 of the evertingballoon 18. A spring within the lever can facilitate the pumping actionof the lever to open the lever (not shown) for each compression.

The system handle 30 can have an advancement slide 48. The advancementslide 48 can be proximally and distally translatable, as shown by arrow50, with respect to the system handle case 34. The advancement slide 48can be configured to translate the inner catheter 16 with respect to theouter catheter 4. For example, pushing the advancement slide 48 distallycan push the inner catheter 8 distally with respect to the outercatheter 4 and evert the everting balloon 18. Pulling the advancementslide 48 proximally can pull the inner catheter 8 proximally withrespect to the outer catheter 4 and retract the everting balloon 18. Theadvancement slide 48 can have gear wheels, ratchets with racks, androtating advancement screws.

The advancement button can be an advancing ratchet or a roller wheelthat is geared into or with the inner catheter 8 to allow fortranslation of the inner catheter 16.

With one hand, the physician can advance the inner catheter 8, evert theeverting balloon 18, traverse the cervical canal with the evertingballoon 18, and access the uterine catheter through the inner catheterlumen 10.

The fluid reservoir 42 can be pressurized prior to placement of thedistal tip of the outer catheter 4 at the cervix. The fluid reservoir 42can has a proximal check or one-way valve on the proximal portion of thehandle. The proximal check valve is the connection point for thephysician to pressurize the system. The distal portion of the fluid bagcan be attached to a distal pressure check valve 52 that can open whenpressure from the fluid bag is at or above a distal check valve limitpressure, for example about 1 atmosphere of pressure from the liquidreservoir, and then deliver liquid and pressure from the liquidreservoir 42 to fill and pressurize the media volume 12 of the cathetersand everting balloon 18. The distal pressure check valve 52 can be aone-way valve allowing hydraulic or pneumatic fluid or media to go fromthe fluid reservoir 42 to the media volume 12 of the catheters andeverting balloon 18. Higher and lower atmosphere pressure ratings from 1atmosphere are also possible for the distal pressure check valve 52 suchas from about 0.5 atmospheres to about 2 atmospheres.

During pressurization of the fluid reservoir 42 (e.g., by pumping withthe pump lever 36 or from the inlet port via the proximal check valve54), pressures greater than a reservoir limit pressure (e.g., 1atmosphere) of the distal pressure check valve 52 can open the distalpressure check valve 52 and allow fluid media to flow from the liquidreservoir 42 into the media volume 12 of the catheters and evertingballoon 18. The pressurization in the media volume 12 of the cathetersand everting balloon 18 can unroll and evert the everting balloon 18under hydraulic force. Excess media can remain in the fluid reservoir 42after the everting balloon 18 fully everts.

The distal pressure valve 52 can be connected to a three-way connector56 (e.g., Y-connector or T-connecter) that has a hemostasis valve 58,for example a Touhy-Borst valve. Thus the fluid reservoir 42 can stageor hold additional potential hydraulic pressure to be stored in thesystem for the user (e.g., physician) to use as needed by rotating thepump lever 46 without a change of hand position or the use of a secondhand.

The inner catheter 8 can extend through the three-way connector 56. Theinner catheter 8 can translate (i.e., advance and retract) through thethree-way connector 56 while maintaining a seal (i.e., without the mediavolume 12 of the catheters or everting balloon 18 losing pressure). Theinner catheter 8 (e.g., if a solid rod or mandrel) can be configured towithstand hydraulic pressures of up to about 5 atmospheres or up toabout 10 atmospheres during the everting process and translational(e.g., advancement, retraction, tensile, compression, or combinationsthereof) forces of up to about 2 pounds or up to about 5 pounds withoutdeformation. As an example, during the everting process the innercatheter 8 with an inner catheter lumen 10 (e.g., a through lumen) couldwithstand media pressures 14, tensile and compressive forces, androtational forces as the everting balloon membrane 6 traverses curved ortortuous anatomy, to allow for the passage of an instrument, catheter,media, or materials within the through lumen. Movement of theadvancement button on the handle moves the inner catheter 8 within thethree-way connector 56 and through the outer catheter 4. The evertingballoon 18 can then evert and roll out of the outer catheter 4 andtraverse the target site (e.g., the cervical canal).

After accessing the target site, for example, the user can activate thepressure release control 60 to release or reduce the pressure from themedia volume 12 thereby deflating or reducing the outer diameter of theeverting balloon 18, and/or manually withdraw the everting balloon 18and inner catheter 8 by retracting the advancement slide 48 or pullingthe system handle 30 proximally, and therefore the remainder of thesystem.

Once the biological lumen to be traversed (e.g., the cervical canal, orurethra) is traversed by the everted balloon 18, the everting balloonsystem 2 can increase the pressure in the everting balloon 18, forexample increasing the diameter of the everting balloon 18, or whilemaintaining a constant diameter everting balloon 18 (e.g., for afiber-reinforced everting balloon 18 or a balloon membrane 6 constructedfrom a less distensible material). The pump lever 36 can be compressedto increase pressure in the fluid reservoir 42 builds and exits thedistal pressure check valve 52. The proximal check valve 54 can preventor minimize the fluid media (e.g., pneumatic or hydraulic pressure) fromleaking or bleeding in the proximal direction and out of the inlet port40.

The user can rotate the pump lever 36, for example increasing thepressure in the fluid reservoir 42, the media volume 12, and theeverting balloon 18. The balloon outer diameter can then increase,further pushing open the diameter of the biological lumen. For example,the everting balloon 18 can dilate the cervix and cervical canal. Toolssuch as endoscopes, instruments, Hegars, other devices to increase thediameter of the cervix further, or combinations thereof, can then beinserted into the dilated cervical canal concurrent with the evertingballoon system 2 being located in the cervical canal or subsequent tothe everting balloon system 2 being withdrawn from the cervical canal.

The pump lever 36 can deliver tactile feedback to the user indicatingthe pressure of the everting balloon 18. The everting balloon system 2can have a pressure gauge indicating the pressure in the media volume12, such as in the liquid reservoir 42 and/or the media volume 12 in thecatheters and everting balloon 18.

The system handle 30 can have a pressure release control 60, such as atoggle lever or knob. The pressure release control 60 can release fluidfrom the liquid reservoir 42 and/or media volume 12 of the catheters andeverting balloon 18.

The pressure release control 60 can be connected to the hemostasis valve58. The hemostasis valve 58 can have a seal or sealing gasket. Thepressure release control 60 can be configured to open and close thesealing gasket by rotating the sealing cap, or open a connection to aseparate drainage tube (not shown) in fluid communication with the mediavolume 12.

The pressure release control 60 can be on the handle 30 positioned bythe user's thumb position, distal to and collinear with the movement ofthe advancement slide 48. The pressure release control 60 can beoperated by the same hand as the user is operating the advancement slide48 and pump lever 36.

The pressure release control and handle can be used to advance anddeliver an IUD with one hand by the user.

The user can perform the following operations of the everting balloonsystem 2 with a single hand (e.g., without their other hand or anotheroperator) without a change of hand position:

-   -   a. pressurize the liquid reservoir 42;    -   b. position or place the distal end of the everting balloon        system 2 at the patient's cervix;    -   c. control the everting balloon system 2 position throughout        use;    -   d. advance the inner catheter 8 and balloon membrane 6;    -   e. increase the diameter of the everting balloon 18 by pumping        additional hydraulic pressure from the fluid reservoir 42;    -   f. retract the inner catheter 8 and balloon membrane 6; and    -   g. activate the pressure release control 60 to remove or release        pressure from the everting catheter system.

Structurally, the buttons and actuators to enable these functions can bepositioned on the handle to allow for the operator to manipulate thesefeatures without a change of hand position or requiring the use of theother hand. For instance, advancement and retraction of the innercatheter 8 can be performed by a slide mechanism or gear wheels that arelocated on the upper side of the handle approximately 4 inches from theproximal end of the handle or handle grip. Levers and ratchet mechanismscan be located on the lower or underneath side of the handle at adistance of from about 2 inches to about 4 inches from the proximal endof the handle grip. Additional actuators can be placed on the lateralsides of the handle grip from about 3 inches to about 4 inches from theproximal end of the handle grip or on the upper or lower portions of thehandle grip from about 3 inches to about 4 inches from the proximal end.The button and actuator position can be palpable for the operatorwithout requiring visual confirmation, thereby allowing the user tomaintain eye contact with the patient or visualization source such as anendoscopic monitor or ultrasound image.

During the use of the everting balloon system 2, the user can utilizetheir other hand for handling an ultrasonic probe, a tenaculum (e.g., ifthe cervix is difficult to access by anatomical reasons or is severelyretroverted or anteverted), stabilizing the patient or otherinstruments, or combinations thereof.

FIG. 3A illustrates that the inner catheter 8 can be attached to adilating balloon 62 or inner catheter balloon. The dilating balloon 62can be radially inside of the everting balloon 18. The distal end andthe proximal end of the dilating balloon 62 can be attached and sealedto the inner catheter 8. The inner catheter 8 can have a dilatingballoon port 64 longitudinally within the dilating balloon 62. Thedilating balloon port 64 can be in fluid communication with a fluidpressure source at the proximal end of the everting balloon system 2,for example in or attached to the system handle 30. The dilating balloon62 can be inflated and deflated through the dilating balloon port 64.

The dilating balloon 62 can be more, the same, or less compliant thanthe everting balloon 18. The everting balloon 18 wall can be thicker,thinner, or the same thickness as the dilating balloon 62 wall. Theeverting balloon 18 can be made from one or more polymers includingsilicone, urethane, rubber, latex, polyethylene, polyolefin, irradiatedpolyolefin combined with ethylene vinyl acetate, co-polymers such aspolyether block amide (PEBA, also known as Pebax), a fiber-reinforcedpolymer, PET, nylon, or combinations thereof. The dilating catheter canbe made from any of the materials mentioned for the everting balloon 18.

The everting and/or dilating balloon membrane 6 can have a thicknessfrom about 0.001 in to about 0.004 in.

The everting and/or dilating balloon 18, 62 can be internally coatedwith a lubricious material such as silicone oil, mineral oil, otherlubricant, or combinations thereof. The lubricous coating can reduce thefriction within the balloon during eversion.

The exterior of the everting and/or dilating balloon 18, 62 can besmooth, for example the balloon can be made by tubing extrusion. Theballoons can be blow molded. For example, the exterior surface of theballoon can have ridges or other surface protrusions, for example toincrease friction or holding forces in the target body lumen (e.g.,cervical channel or urethra). The outer diameter of the balloons canvary dimensionally. For instance, the most distal portion of theeverting balloon 18 can be manufactured with a larger outer diameter toaccommodate larger vessel sizes or inflation that can extend into thebladder.

During use, the everting balloon 18 can pull the inner catheter 8 intothe endocervical canal. When the everting balloon 18 is deployed intothe cervical channel, the dilating balloon 62 can be positioned in thecervical channel.

FIG. 3B illustrates that the dilating balloon 62 can be inflated bydelivering pressurized fluid through the dilating balloon inflation port64. The dilating balloon 62 can expand inside of the everting balloon18. The dilating balloon 62 can inflate to a dilating balloon diameter66.

The dilating balloon 62 can have a predetermined or molded size andshape. For example, the dilating balloon 62 can have a dilating balloondiameter 66. For example, the maximum dilating balloon diameter 66 ormaximum everting balloon diameter can be from about 2 mm to about 12 30mm, and for some applications, up to about 20 mm in diameter (e.g., foruse in a cervix), and more narrowly from about 2 mm to about 10 mm(e.g., for use in a urethra), more narrowly from about 6 mm to about 12mm, yet more narrowly from about 2 mm to about 7 mm (e.g., for use in aurethra), yet more narrowly from about 3 mm to about 4 mm (e.g., for usein a male urethra). The dilating balloon 62 can inflate to a presetouter diameter. (The dilating balloon outer diameter 66 can be equal toor less than the dilating diameter needed for the body lumen, such asthe cervix.) The everting balloon 18 can have a maximum everting balloondiameter equal to or less than the maximum dilating balloon diameter 66.

The dilating balloon 62 can be inflated to the same or a higher pressurethan the everting balloon 18. For example, the dilating balloon 62 canhave a dilating balloon pressure from about 4 atmospheres to about 12atmospheres of pressure, and up to about 20 atmospheres of pressure, forexample for disrupting a pathological stenosis or condition within abodily lumen.

When the dilating balloon 62 is inflated, the everting balloon 18 canstretch due to the expanding dilating balloon 62 to the dilating balloondiameter 66. The inflation media within the everting balloon 18 canremain inside the balloon or be withdrawn before, during, and/or afterinflation of the dilating balloon 62. Due to the frictional forces ofthe everting balloon membrane 6 on the bodily lumen in the evertedstate, for example, the everting balloon membrane 6 can serve tomaintain the position of the dilating balloon 62 during the dilationprocess without unintentional advancement or retraction of the systemwithin the bodily lumen during the dilatation process.

The dilating balloon 62 can inflate and tear or break the evertingballoon 18 as the everting balloon diameter expands beyond the strainlimit for the everting balloon 18. The inflation media within theeverting balloon 18 can remain inside the balloon or be withdrawnbefore, during, and/or after inflation of the dilating balloon 62, forexample exiting the everting balloon 18 can exit when the evertingballoon 18 tears open.

The everting balloon 18 can break or tear along an intentional line uponthe inflation of the dilating catheter. For example, the evertingballoon 18 can be torn by a mechanical instrument on or within the outercatheter 4, a sharp implement on the proximal portion of the innercatheter 8 that becomes active upon full eversion and inflation of thedilating balloon 62, and/or further advancement of the inner catheter 8that disengages the attachment or bond between the everting balloon 18and the inner catheter 8 on the distal end of the inner catheter 8. Thetearing or splitting of the everting balloon 18 can be done be weakeningthe everting balloon 18 with a mechanical indentation or seam on theballoon membrane 6 that splits upon reaching a specific strain limit,such as along a helical line, lateral line, longitudinal line, orcombinations thereof. The everting balloon membrane 24 can bemanufactured with increased longitudinal axial orientation of themolecular structure by tensioning or expanding the membrane along thelongitudinal axis of the balloon during the balloon forming processwhich can promote a longitudinal break if the everting balloon membrane24 splits or tears. A radial tear in the everting balloon 18 can bepromoted by manufacturing the balloon membrane 6 with greater radialorientation of the molecular structure by radially expanding ortensioning the balloon membrane 6 during the balloon forming process.

The system handle 30 can hold the inflation media to be delivered to andfrom the everting balloon 18 and the dilating balloon 62. The inflationmedia can be in the liquid reservoir 42 (e.g., the fluid bag or asyringe piston). The inflation media can be delivered, for example viavalves, to the dilation balloon after the inflation and eversion of theeverting balloon 18. The system handle 30 can have gear wheels or aratchet configured to advance the inner catheter 8. The outer catheter 4can extend about 25 cm distal to the system handle 30. The system handle30 and actuators can inflate the everting balloon 18 and dilatingballoon 62 from control with one hand.

The dilating balloon 62 can be positioned into and dilate the cervix.

FIGS. 4A through 4C illustrate that the inner catheter 8 can be in afully retracted position inside of the outer catheter 4.

FIG. 4A illustrates that the system handle 30 can have a pump lever 36,such as a ratchet handle 68, a syringe connector 70, and a plunger driveplate 72. The ratchet handle 68 can have a finger grip, trigger, lever,pump mechanism, or combinations thereof. The fluid reservoir can be asyringe 74. The syringe 74 can have a volume from about 5 cc to about 20cc, for example about 5 cc or about 20 cc. An open distal port of thesyringe can be attached to and in fluid communication with the syringeconnector 70. The syringe connector 70 can have the distal pressurevalve 52. The syringe connector 70 can be rotatably attached to thesystem handle case 34. The syringe 74 can have a plunger 76longitudinally translatable with the remainder of the syringe 74. Thesyringe 74 can be filled with any media disclosed herein, such assaline, air, gas, or combinations thereof. The liquid reservoir 42 canhave two separate syringes 74, each attached to and in fluidcommunication with the same or different syringe connectors 70. Forexample, a first syringe can be in fluid communication with the evertingballoon 18, and the second syringe can be in fluid communication withthe dilation balloon 62.

The syringe 74 can be locked to the syringe connector 70.

The outer catheter 4 can have an outer catheter distal tip 78. The outercatheter distal tip 78 can be, for example, an atraumatic tip such as anacorn tip or stop. The outer catheter distal tip 78 can be configured toprevent insertion of the outer catheter 4 too far into the targetbiological lumen (e.g., the endocervix).

The outer catheter distal tip 78 can have an outer catheter distal port80. The outer catheter distal port 80 can be large enough to allow theinner catheter 8 and balloons to pass through.

FIG. 4B illustrates that the syringe connector 70 and syringe 74 canrotate, as shown by the arrow, so the longitudinal axis of the syringe74 can be parallel or collinear with the longitudinal axis of the outercatheter 4. The syringe connector 70 can be angularly fixed with respectto the rest of the system handle 30. The plunger drive plate 72 can berotated and/or translated to contact or almost contact the proximal endof the syringe plunger 76.

FIG. 4C illustrates that the system handle 30 can have a plunger driver82. The plunger driver 82 can have a linear rack or plunger drive screw84, plunger drive collar 86, and plunger drive plate 72. The ratchethandle 68 can be squeezed to rotate the plunger drive screw 84, as shownby arrow 87, or linear rack. The plunger drive screw 84 or linear rackcan be configured to translate the plunger drive collar 86. For example,the plunger drive collar 86 can have internal threads engaging withouter threads of the plunger drive screw 84. The plunger drive collar 86can be translatably fixed to the plunger drive plate 72. The plungerdrive collar 86 and plunger drive plate 72 can translate distally withrespect to the remainder of the syringe 74 when the ratchet handle 68 issqueezed. The plunger drive plate 72 can be in contact with and pressthe plunger 76 in a distal direction as shown by arrow.

The ratchet handle 68 can have a ratchet to prevent reversing thedirection of the plunger driver, for example to prevent proximaltranslation of the plunger 76. A release lever can be rotated ordeployed to release the ratchet mechanism for disengagement of theassembly, withdrawal of the system, or redeployment. The ratchet handle68 can have no ratchet or a two-way ratchet, for example controlling thedirection of the plunger driver 82, for example to allow proximal anddistal translation of the plunger 76. The plunger drive plate 72 can befixed to or touching but unfixed to the plunger 76.

Squeezing the ratchet handle 68 can depress the syringe plunger 94.Depressing the syringe plunger 94 can force inflation media from thesyringe 74 to the media volume 12 of the dilation and/or evertingcatheter 18, for example pressurizing the respective balloons.

FIGS. 5A through 5F illustrates that the system handle 30 can have astop cock and check valve 88 extending from the three-way connector 56.The stop cock and check valve 88 can be in fluid communication with themedia volume 12. The stop cock and check valve 88 can be outside (asshown) or inside of the system handle case 34. The stop cock and checkvalve 88 can be accessed to add media, remove media, or check thepressure of the media in the media volume 12.

The system handle 30 can have one or more syringe detents 90. Thesyringe detents 90 can removably attach to a portion of the syringe 74to prevent or minimize longitudinal translation of the syringe 74 withrespect to the system handle case 34. The syringe detent 90 can beconfigured to allow the syringe 74 to slide in and out of the detenttransverse to the longitudinal axis of the syringe 74.

The system [[case]] handle case 34 can have a deflecting plate 92. Theouter and/or inner catheters 4, 8 can press against the deflecting plate92. The deflecting plate 92 can alter or deflect the path of the outerand inner catheters 4, 8 towards the longitudinally axial direction ofthe target site. The deflecting plate 92 can have a molded or formedgroove, pins, plate, panel, or combinations thereof. The outer catheter4 can be manufactured with a preset curve to accommodate the curved pathwithin the system handle case 34.

The system handle case 34 can have a handle grip 96. The inner catheter8 can have a linear inner catheter grip length 98. The inner cathetergrip length 98 can be a length of the inner catheter 8 in the unevertedstate in the handle grip 96. The inner catheter grip length 98 can beabout 12 cm of inner catheter 8 in the uneverted state, for examplecorresponding to an eversion length for the inner catheter grip length98 of about 6 cm (e.g., about 50% of the inner catheter grip length 98)of everted balloon membrane 24. Alternatively, the inner catheter 8 canbe configured to coil up on wheel, have telescoping segments, or havefolding and unfolding segments, to reduce the amount of distance neededwithin a system handle case 34 to accommodate the length of innercatheter 8 in the uneverted state.

The system handle 30 can have a reservoir-catheter channel 100, forexample in fluid communication with the distal end of the syringe 74 andthe proximal end of the inner catheter 8. The reservoir-catheter channel100 can be a tube from the syringe connector 70 to the inner catheter 8.

The system handle 30 can have an access channel 102 extending from anexternal surface of the system handle connector 32 to an externalsurface of the system handle case 34. The access channel 102 canproximally terminate at a proximal access port 104.

The inner catheter 8 can extend through the access channel 102. One ormore tools or fluids can be inserted through, and/or suction can beapplied to, the proximal access port 104 and access channel 102 into andthrough or adjacent to the inner catheter 8.

The system handle 30 can have one or more drive gears 106. The drivegears 106 can be on one or opposite sides of the access channel 102. Thedrive gears 106 can encroach or impinge into the access channel 102. Thedrive gears 106 can be rotatably attached to the system handle case 34via drive gear axles 108. The drive gears 106 can have teethed gearsections and drive gear grooves 124. The inner catheter 8 can extendthrough the drive gear grooves 124. The drive gears 106 can frictionallypush and pull the inner catheter 8. One or more of the drive gears 106can extend and be exposed out of the system handle case 34. For example,the exposed drive gears 106 can be rotated by pressing on the exposeddrive gear 106 with the user's palm or digit (e.g., thumb). The exposeddrive gear 106 can be interdigitally engaged with one or morenon-exposed drive gears 106. Rotating a first one of the drive gears 106can rotate other drive gears 106 interdigitally engaged with the firstdrive gear 106.

The system handle case 34 can have a system handle case first lateralportion 110 and a system handle case second lateral portion 112. Thesystem handle 30 can be made by attaching the system handle case firstlateral portion 110 to the system handle case second lateral portion112. Each drive gear axle 108 can be rotatably attached to the systemhandle case first lateral portion 110 and the system handle case secondlateral portion 112.

The pump lever axle can be a ratchet handle axle 114. The ratchet handle68 can rotate around the ratchet handle axle 114.

The system handle 30 can have a plunger drive rack 116. The plungerdrive rack 116 can be fixed to the plunger drive plate 72. The plungerdrive plate 72 can extend perpendicularly from the proximal end of theplunger drive rack 116. A side of the plunger drive rack 116 facingtoward the plunger drive plate 72 can have unidirectional orbidirectional drive teeth 118.

The system handle 30 can have a ratchet handle spring 120 compressedbetween the system handle case 34, and/or the ratchet handle 68, and/ora ratchet arm 122. The ratchet handle spring 122 can reset the ratchethandle 68, for example by rotating the ratchet handle 68 forward, afterthe ratchet handle 68 has been squeezed.

The system handle 30 can have the ratchet arm 122 or actuating pawl. Theratchet arm 122 can be mechanically attached to the ratchet handle 68,for example to the handle spring 120. The ratchet arm 122 can be in atrack limiting motion of the ratchet arm 122 to translation in thelongitudinal direction with respect to the syringe 74. The proximalterminal end of the ratchet arm 122 can be curved in a u-shape. Theterminal end of the ratchet arm 122 can press against a ratchet tooth.The ratchet arm 122 can be configured to pull the plunger drive rack 116distally when the ratchet handle 68 is squeezed. The ratchet arm 122 isconfigured to move proximally with respect to the plunger drive rack 116when the ratchet handle 68 is returned to a reset position.

The system handle 30 can have a locking pawl (not shown) can bespring-loaded between the system handle case 34 and the plunger driverack 116, for example, allowing distal translation of the plunger driverack 116 and preventing proximal translation of the plunger drive rack116 except when the locking pawl is manually released from the plungerdrive rack 116 by the release lever 126.

The outer catheter 4 can have an outer catheter length 128, as shown inFIG. 5B. The outer catheter length 128 can be from about 4 cm to about35 cm, more narrowly from about 10 cm to about 24 cm, for example about17 cm.

FIGS. 6A through 6D illustrate that the system handle 30 can have aninner catheter drive tray 130 translatably attached to the system handlecase 34. A proximal length of the inner catheter 8 can extend proximallyfrom the system handle case 34. The proximal length of the innercatheter 8 can be in, on, or adjacent to the inner catheter drive tray130.

The syringe 74 can have a syringe loading connector 132, such as a luerconnector, at the terminal distal or proximal end of the syringe 74(e.g., the end further from the system handle case 34). A delivery tube133 or delivery device can be attached to the syringe loading connector132 and pressurized media can be delivered through the syringe loadingconnector 132 into the syringe 74.

The delivery tube 133 or delivery device can be disconnected from thesyringe loading connector 132 before deploying the everting balloon 18,as shown in FIG. 6C. The delivery tube 133 can wrap inside the handlegrip 96 and connect the syringe 74 and its pressurization media to thethree-way connector 56 and the hemostasis valve 58 or inlet port 40 forthe dilation balloon 62.

The proximal terminal end of the inner catheter 8 can be attached to theproximal access port 104. The proximal end of the inner catheter drivetray 130 can have one or more access port detents 134. The access portdetents 134 can attach to the proximal access port 104. The access portdetents 134 can removably attach to a portion of the proximal accessport 104 to prevent or minimize longitudinal translation of the proximalaccess port 104 with respect to the inner catheter drive tray 130. Theaccess port detent 134 can be configured to allow the proximal accessport 104 to slide in and out of the access port detents 134 transverseto the longitudinal axis of the inner catheter drive tray 130.

The inner catheter drive tray 130 can be translated along thelongitudinal axis of the inner catheter drive tray 130 to translate theinner catheter 8 (e.g., advance the inner catheter 8 into the targetsite). The inner catheter can deliver an IUD, instrument, device,endoscope, or a dilating balloon.

The system handle case 34 can have a fluid connection between thesyringe 74 and the outer catheter 4, as disclosed herein.

The ratchet arm 122 can extend away from the drive rack 116 to form arelease lever 126, as shown in FIG. 6A. One or more other release levers126 can extend from other locations on the system handle 30, as shown inFIGS. 6B and 6D. The release lever 126 can be rotated to disengage theratchet arm 122 from the drive rack 116.

The ratchet handle 68 can have a safety lock hole 136. A safety lockhaving a cable or rod can removably extend through the safety lock hole136, for example to create an interference fit against the system handlecase 34 and prevent rotation of the ratchet handle 68, for examplepreventing unintentional or premature media delivery from the syringe74.

The ratchet handle 68 can be laterally split into a catheter sub-handle138 and a media sub-handle 140. The catheter sub-handle 138 can beconfigured to control the advancement of the inner catheter drive tray130. The media sub-handle 140 can be configured to control the pressureof media delivery from the syringe 74. The catheter sub-handle 138 canbe attached to an inner catheter drive rack. The media sub-handle can beattached to a plunger drive rack.

The ratchet handle 68 can control the syringe 74 for applying mediapressure to the everting balloon 18 and dilating balloon 62, andindependently control the translational movement of the inner catheter8.

FIGS. 7A and 7B illustrate that the inlet port 40 can have a female luerconnector. The system handle connector 32 can have a female luerconnector. The outer catheter distal tip 78 can have a soft rubber orpolymerized acorn tip, for example, to assist in stabilizing theeverting system 2 at the opening of the bodily lumen or preventingunintentional advancement of the outer catheter 4 within the bodilylumen.

The reservoir-catheter channel 100 can extend from the three-wayconnector 56 and out of the system handle case 34. The proximal terminalend of the reservoir-catheter channel 100 can be attached to a femaleluer connector and/or the distal pressure valve 52. The distal pressurevalve 52 and/or female luer connector can be connected to the liquidreservoir 42 (not shown).

FIG. 8A illustrates that the three-way connector 56 can have ahemostasis valve 58. The three-way connector 56 can have or be aTouhy-Borst Y-connector. The inner catheter 8 can extend through thethree-way connector 56.

The three-way connector 56 can have a distal gasket 142 between thereservoir-catheter channel 100 and the system handle connector 32. Thedistal gasket 142 can have a cylindrical distal gasket port 144extending through the radial middle of the distal gasket 142. The distalgasket port 144 can have a distal gasket port diameter.

The three-way connector 56 can have a proximal gasket 146 proximal tothe distal gasket 142. The proximal gasket 146 can be between thereservoir-catheter channel 100 and the proximal outlet through which theinner catheter 8 proximally exits the three-way connector 56. Theproximal gasket 146 can be more, the same, or less compliant than thedistal gasket 142. The proximal gasket 146 can have a cylindricalproximal gasket port 148 extending through the radial middle of theproximal gasket 146. The proximal gasket 146 can have a proximal gasketport diameter.

The inner catheter 8 can have an inner catheter small diameter length150 and an inner catheter large diameter length 152 proximal to theinner catheter small diameter length 150. The inner catheter 8 can havean inner catheter proximal inflation hole 154 at the distal end of theinner catheter large diameter length 152. The inner catheter proximalinflation hole 154 can be in fluid communication with the open distalend of the inner catheter lumen 10 and/or the dilating balloon port 64.

Positive media pressure 14 or flow can be delivered, as shown by arrows,through the reservoir catheter channel 100 to the three-way connector56. The inner catheter large diameter length 152 can occlude, plug,and/or seal the proximal gasket port 148. The positive media pressure 14or flow can be delivered through the gap between the outer diameter ofthe inner catheter 8 (e.g., along the inner catheter small diameterlength 150) and the inner diameter of the distal gasket port 144 and tothe media volume 12 between the outer catheter 4 and the inner catheter8, for example to the everting balloon 18.

FIG. 8B illustrates that the inner catheter 8 can be translateddistally, as shown by arrow, at least until the inner catheter largediameter length 152 moves into the distal gasket port 144. The innercatheter large diameter length 152 can slide through the proximal gasketport 148. The inner catheter large diameter length 152 can occlude,plug, and/or seal the distal gasket port 144 and/or against the distalgasket 142. The media 155 flow from the reservoir-catheter channel 100can be forced to flow into the inner catheter proximal inflation hole154. The media 155 can flow down the inner catheter lumen 10, forexample to the dilating balloon 62.

An exemplary procedure for delivering an IUD (not shown) or dilating abody lumen such as the cervical canal can include:

-   -   1. The syringe 74 can be loaded onto the system handle 30. The        system handle 30 can be a separate, reusable item in which the        everting catheter and syringe filled with media 155 can be        attached to the remainder of the system before use.        Alternatively, the system handle 30 can come supplied to the end        user preassembled with the remainder of the system and        pre-filled, or combinations thereof.    -   2. The distal end of the everting balloon system 2 can be placed        at the exocervix.    -   3. The ratchet handle 68 can be depressed. The first one to two        clicks of the ratchet (i.e., as the locking pawl passes over        ratchet teeth) can depress the syringe plunger 94 and pressurize        the everting balloon 18. The everting balloon 18 can be        pressurized to 4 to 6 atmospheres.    -   4. The ratchet handle 68 can be depressed further (or released        to rotationally reset and then depressed further). The next sets        of clicks on the ratchet handle 68 can indicate advancement the        inner catheter 8. This can be accomplished by the ratchet        mechanism rotating gear wheels on the inner catheter 8 and/or        translating a linear rack to advance the inner catheter 8.    -   5. The ratchet handle can be depressed further (or released to        rotationally reset and then depressed further). The advancement        of the inner catheter 8 can continue until the everting balloon        is fully deployed and everted. The dilation balloon 62 can be        positioned on the distal end of the inner catheter 8.    -   6. The ratchet handle 68 can be depressed further. The next        click of the ratchet can de-pressurize the everting balloon 18        or deliver an IUD (not shown).    -   7. The ratchet handle 68 can be depressed further. The next        click of the ratchet can change the pressurization outlet of the        syringe 74 from the everting balloon 18 to the dilation balloon        62 or this action can deliver an IUD (not shown). This can be        accomplished, for example, by:        -   a. rotating a valve with the ratchet mechanism,        -   b. manually rotating the valve, and/or        -   c. advancing the inner catheter 8 to where the inner            catheter proximal inflation hole 154 or port is exposed to            the inflation media, such as shown in FIGS. 8A and 8B.    -   8. The ratchet handle 68 can be depressed further. The next sets        of clicks on the ratchet can indicate the inflation of the        dilatation balloon 62.    -   9. The dilatation balloon 62 may rupture the overlying everting        balloon 18.    -   10. The amount of force in the biological lumen dilatation can        be governed by a pressure relief valve or by the amount of        volume of media 155 that can be placed within the dilatation        balloon 62. The dilatation pressure can be monitored by a        pressure gauge in or attached to the system handle case 34. The        dilation balloon 62 can dilate the cervix with from about 6        atmospheres to about 20 atmospheres. The dilation balloon 62 can        initially deliver about 10 atmospheres to about 12 atmospheres        with a reduction in pressure as the cervix dilates and the        dilatation process is completed. The system can deliver a known        volume of media 155 into the dilation balloon 62 irrespective of        quantifying or measuring the media pressure 14.    -   11. The dilatation process may be observed by ultrasound or        radiographic imaging.    -   12. A pressure relief button on the system handle 30 can be        activated to remove or reduce dilatation pressure in the media        volume 12 in the inner catheter lumen 10.    -   13. The syringe plunger 94 may be retracted to draw vacuum from        the inner catheter lumen 10 and dilation balloon 62, for example        loosening the dilation balloon 62 from the cervix, and/or        deflating the dilation balloon 62, for example to facilitate        removal of the everting balloon system 2 from the cervix.    -   14. The everting balloon system 2 can be re-pressurized, for        example if additional dilatation force is desired in the cervix.        For instance, if an additional stenosis in the cervix is        visible, the dilatation balloon 62 can be repositioned and        inflated in the additional stenosis area.

The everting catheter system can access a bodily cavity (e.g., theuterine cavity or fallopian tubes) to deliver or introduce of tools(e.g., IUDs and instruments), reproductive (e.g., embryos, in vitrofertilization (IVF) or insemination products, such as hormones) media155 or material, contrast media, dye, therapeutic agents, sclerosingagents to treat the endometrium, insufflation media, or combinationsthereof to the cavity. For example, reproductive media can be deliveredwith a transfer catheter inserted through the inner catheter lumen 10 tothe uterine cavity.

FIG. 9 illustrates that a transfer catheter 156 or insemination cathetercan have a transfer connector 158, such as a female luer connector, astrain relief length 160, and a transfer tube 162. The transfer tube 162can hold the reproductive media. The transfer tube 162 can have aproximal length having a proximal length diameter larger than a distallength diameter of a distal length of the transfer tube 162. A deliveryforce, for example a positive fluid pressure, can be delivered throughthe transfer connector 158 and strain relief length 160 to push thecontents of the transfer tube 162 into the target site.

The transfer catheter 156 can attach to or inserted through the inletport 40. The transfer tube 162 can hold an embryo, for example for invitro fertilization or IVF. The embryo transfer catheter 156 can deliverembryos through the system and to the uterine cavity. The transfercatheter 156 can hold spermatozoa and through the system and to theuterine cavity for intrauterine insemination procedures. The transfercatheter 156 can hold and deliver other materials the deposition ofdrugs, therapeutic agents, instruments, endoscopes, cytology brushes,other catheters, or combinations thereof through the system and into theuterine cavity. The transfer catheter 156 can be connected to a vacuumsource for the aspiration of materials from the uterine cavity or otherbodily cavities and lumens.

The transfer catheter 156 and/or materials can be loaded in the innercatheter lumen 10 prior to everting the everting balloon 18 within thevessel or bodily cavity. For example in the case of delivery ofreproductive material in the uterine cavity, the transfer catheter 156can be loaded with washed and prepared semen in the transfer tube 162and the transfer catheter 156 can be placed in the inner catheter lumen10.

A guidewire can be inserted through the transfer catheter 156 and/or theremainder of the system, for example to direct the tube or system to thetarget site 164. The guidewire can be used for recanalization.

The inner catheter 8 can be extended and the everting balloon 18 canevert and unroll through the cervix and into the uterine cavity.Concurrently or subsequently, the transfer catheter 156 can be advancedthrough the inner catheter lumen 10 into the uterine cavity. Once fullyeverted or when the transfer catheter 156 becomes extended or exposedfrom the inner catheter 8 and beyond the everting balloon membrane 24,the reproductive material 166 in the transfer catheter 156 can bedeposited by a syringe 74, squeeze bulb, piston, or other pressuresystem. A second delivery catheter, such as a second insemination, IVF,or drug delivery catheter can be concurrently inserted into the inletport 40 or a second inlet port. The second delivery catheter can bedeployed to the target site 164 concurrent with or subsequent to thetransfer catheter 156.

The system handle 30 can have a lead-in area. The lead-in area can, forexample, be without steps, edges, bumps, or restrictions that may impedeor contact the distal opening of the transfer catheter 156 duringpassage, for example so that in the case of delivery of inseminationmaterial, the transfer catheter 156 can be easily loaded into the systemhandle 30. An insemination syringe 74 or pump can be attached to theproximal transfer connector to deliver pressure to the transfer tube162, for example to expel the reproductive material 166 once the distalport of the transfer catheter 156 is positioned at the target site 164(e.g., after the everting balloon 18 is fully deployed). The actuationof the insemination syringe or pump on a pre-loaded transfer catheter156 can be performed by the same hand that holds and operates thecomponents of the everting catheter system.

In addition, the transfer catheter 156 can be configured to beintroduced into the proximal connector in the handle of the evertingcatheter system once the system is fully deployed.

The user can perform any or all of the following while using theeverting balloon system 2, for example with a single hand:

-   -   a. pressurize the everting catheter system;    -   b. position the everting balloon system 2 at the patient's        cervix;    -   c. maintain the everting balloon system 2 position throughout        the procedure;    -   d. advance the inner catheter 8 and everting balloon 18;    -   e. once extended beyond the everting balloon membrane 24 or        inner catheter 8, present the transfer catheter 156 for        deposition into the bodily cavity such as a uterine cavity    -   f. retract the inner catheter 8 and everting balloon 18; and/or    -   g. activate (e.g., toggle) the pressure release lever to remove        or release hydraulic or pneumatic pressure from the media volume        12.

FIGS. 10A through 10C illustrate that the distal end of the evertingballoon can form a balloon check valve 168. The length of the evertingballoon 18 distal to the distal terminal end of the inner catheter 8 canradially contract to form a tight orifice that can be the balloon checkvalve 168. The balloon check valve 168 can be an openable barrier thatcan block or interrupt fluid communication between the inner catheterlumen 10 and the target site 164.

The balloon membrane 6 can have from about 1 mm to about 3 mm ofoverlapping wall at the balloon check valve 168 closing off the innercatheter lumen 10. The strength or closing pressure of the balloon checkvalve 168 can be modulated during use. For example the distance ofoverlap of balloon membrane 6 can be increased or decreased bycontrolling the amount of excursion available for the inner catheter 8and everting balloon membrane 24.

FIG. 10B illustrates that the distal end of the transfer catheter 156can be advanced, as shown by arrow 170, through the inner catheter lumen10, through the balloon check valve 168, and to the target site 164. Thetransfer catheter 156 can penetrate or push open the balloon check valve168 when the transfer catheter 156 moves through the balloon check valve168. When the terminal distal end of the transfer catheter 156 is distalof the balloon check valve 168 and at the target site 164, thereproductive material 166 loaded in the transfer catheter 156 can bedelivered 172 through a distal port of the transfer catheter 156 andinto the target site 164, such as the uterine cavity.

FIG. 10C illustrates that the transfer catheter 156 can be retractedthrough the balloon check valve 168 and the inner catheter lumen 10after the reproductive material is deposited at the target site 164. Theballoon check valve 168 can close as the transfer catheter 156 isretracted through the balloon check valve 168. The balloon check valve168 can maintain a seal between the inner catheter lumen 10 and thetarget site 164 when the transfer catheter advances 170 through, remainsstationary within, and is retracted through the balloon check valve 168.

The reproductive material 166 can be isolated from vacuum effect or theretraction of reproductive material 166 from the target site 164 as aresult of the vacuum forces created by the withdrawal of the transfercatheter 156 through the system once the deposition of reproductivematerial 166 is completed. The balloon check valve 168 can reduce oreliminate vacuum effect for embryo transfer.

The balloon check valve 166 can be a tactile indicator for the physicianwhen passing the transfer catheter 156 through the everting balloonsystem 2. In transfer procedures, depending upon physician preference orpatient anatomy, for example, the amount of insertion of the transfercatheter 156 through the distal end of the everting system can vary frompatient to patient. As the distal end of the transfer catheter 156passes through the balloon check valve 168, the resistance created bythe balloon check valve 168 can be felt by the physician on the proximalend of the transfer catheter 156. Depending upon the length of balloonchosen to act as a balloon check valve 168, the degree or amount ofresistance can be modulated. In some procedural settings there may be acompromised ability to see the amount of insertion of the transfercatheter 156 into the everting balloon 18, or physical depth indicia ormarkings on the proximal end of the transfer catheter 156. Thecompromised ability to see may be due to low light within the procedureroom so that imaging and visualization of monitors can be enhanced. Inaddition, the physical relationship of the physician, embryologist, orother persons or equipment in the procedure room may compromise theability to see easily the amount of insertion into the evertingcatheter. The tactile sensation of the resistance of the balloon checkvalve 168 can create a palpable indicator that the transfer catheter 156is at the distal end of the everting balloon 18.

The everting balloon system 2 can be used to access and seal the uterinecavity, for example, for the deposition of reproductive material 172 forlong duration intrauterine insemination.

FIGS. 11A through 11C illustrate that the everting balloon membrane 24can create a seal within the cervical canal (e.g., against the cervicalcanal walls 174) as the everting balloon 18 traverses the cervicalcanal. FIG. 11A illustrates that the everting balloon membrane 24 canunroll and advance along the cervical walls, as shown by arrows, as theballoon is pressurized and the inner catheter 8 is distally advanced.The outer catheter 4 can also seal against the cervical canal wall 174.For example, the outer catheter 4 outer diameter can be equal to theeverting balloon outer diameter.

FIG. 11B illustrates that the transfer catheter 156 can advance distallywithin the everting balloon 18 and the inner catheter lumen 10. Thetransfer catheter 156 can deposit the reproductive material 166 (e.g.,sperm) within the uterine cavity 176.

FIG. 11C illustrates that the transfer catheter 156 and/or the innercatheter 8 can be retracted (e.g., from about 3 mm to about 10 mm) orinverted, as shown by arrows, to close the distal end of the innercatheter lumen 10, as shown by arrows, with respect to the uterinecavity 176. The distal opening of the balloon 178 can close, for exampledue to the pressure within the everting balloon 18 forcing the evertingballoon 18 to form the balloon check valve 168. The balloon check valve168 can seal the cervical canal and the uterine cavity 176 from theinner catheter lumen 10. The reproductive materials 166 can remain inthe uterine cavity 176 without being expelled through the cervix.

FIGS. 12A to 12E illustrate of an everting catheter for performing anIUD placement procedure. FIG. 12A shows an everting catheter with an IUDcontained in an everting catheter system 2 in the inverted membraneposition. Everting membrane and IUD (not visible in this figure) arecontained within outer catheter 4 with acorn tip 242 at the distal end.Acorn tip 242 can have an opening at the distal end (not visible). Onthe proximal end of outer catheter 4 there is a t-fitting or Y-fitting244 which contains an x-ring gasket (not visible). Extension tubing andstopcock 248 supplies inflation or hydraulic energy to the evertingcatheter system. Hydraulic energy can be supplied by saline, air, acombination of saline and air, or gases such as CO2, contrast media,culture media, and other fluids. In operation, hydraulic energy can bein the range of 2 to 4 atmospheres, or 1 to 6 atmospheres. Innercatheter 8 is translatable within the outer catheter 4 to advance andretract the everting membrane (not visible). On the proximal end of theinner catheter 8 there is a proximal hub 246 that is designed to allowpassage of the IUD suture 252. Other embodiments may not require the IUDsuture to be exposed from the inner catheter.

FIG. 12B shows the distal end of the everting catheter with IUD 254visible in the everted membrane which is only partially everted fromacorn tip 242. IUD 254 can be in a collapsed condition within themembrane 6. IUD suture 252 can be proximal to the IUD 254. The IUDsuture 252 can be within the central lumen of inner catheter 8. IUD 254can have rounded distal ends 256 and stem 258. IUD 254 can haveradio-opaque marker band 260, copper or drug or hormone eluting section262, and other features.

FIG. 12C shows the advancement of the everting membrane 6 pulling IUD254 through the distal end of outer catheter 4 and opening on acorn tip242. Eversion of the membrane can be performed in response to hydraulicenergy or pressure within the everting catheter system 2 through theinflation tubing and stopcock (not shown). The everting membrane 6responds to hydraulic energy to roll inside out. The advancement of theeverting membrane 6 can be performed by the user translating the innercatheter (not visible) or automatically in response to the hydraulicenergy. The everting membrane can be dimensioned in a range of 1 mm to 5mm in diameter for the endocervical canal or 4.0 to 4.5 mm in outerdiameter when pressurized to 2 atmospheres. The everting membrane canhave an outer diameter range of 2 mm to 7 mm, with a wall thickness of0.001″ to 0.004″, or 0.0015″. The everting membrane can be manufacturedfrom irradiated polyolefin, polyurethane, Pebax, silicone, or otherflexible membrane material. The everting membrane wall thickness couldhave a range of 0.002″ to 0.010″ depending upon the modulus of themembrane material.

FIG. 12D shows the distal end of the outer catheter 4 and acorn tip 242with everting membrane 6 in a further stage of eversion advancing IUD254 through the distal end opening in acorn tip 242. Rounded ends 256 ofIUD 254 are in the initial stages of returning to its natural state asopposed to its collapsed state. In its natural state, IUD 254 can have a“T” or “Y” shape although other shapes and configurations are possiblefor intrauterine devices.

FIG. 12E shows the completion of the eversion process with evertingmembrane 6 advanced further beyond the acorn tip 242 and fully exposingIUD 254 that can now be in its natural (i.e., unbiased or mechanicallyrelaxed) state or “T” shape. Stem 258 and hormone or drug elutingsection 262 are fully exposed from the distal end of membrane 6. CertainIUDs are equipped with bands or rings of copper material as aspermicidal agent. IUD suture 252 can still be within the central lumenof membrane 6 and inner catheter (not visible). At full exposure outsideof membrane 6, IUD 254 can be at the insertion depth within the uterinecavity. The insertion depth of the IUD 254 within the uterine cavity canbe determined or prescribed by the length of the membrane 6, the amountof eversion performed by the user during the translation of the innercatheter 8, which can vary depending upon the desired depth ofinsertion. In addition, the outer catheter 4 can be configured withtelescoping tubes (not shown) that can change the membrane length andthe insertion depth within the uterine cavity.

FIGS. 13A to 13I illustrate additional derivations for an evertingcatheter system 2 for IUD placement. FIG. 13A shows everting cathetersystem 2 with IUD 254 in a collapsed state within the everting membrane6 (not visible) within outer catheter 4. Inner catheter 8 can beproximal to Y-fitting 244 and continues within outer catheter 4.Everting membrane 6 can be connected to the distal end of inner catheter8 and to the distal end of outer catheter 4. Acorn tip 242 can belocated at the distal end of outer catheter 4. Everting membrane 6 canbe pressurized by fluid, gas, or a combination of both through extensiontubing and stopcock 248. Within inner catheter 8 can be pusher 264 whichcan be proximal to inner catheter hub 246. Pusher 264 can be a hollowtube with pusher hub 266 that can contain IUD suture 252 within itsinner lumen.

FIG. 13B shows in a side view acorn tip 242 with dashed lines indicatingthrough lumen 276 within the acorn tip. Acorn tip 242 can be used toseat the everting catheter system 2 at the exocervix of the patient.Acorn tip 242 contains intubation tip 268 on the posterior surface thatcan be designed to gain purchase or intubate the opening of cervix witha rounded surface 269 on the anterior portion. Acorn tip 242 can haveouter shoulders 270 to provide a stopping mechanism to avoid inadvertentinsertion of the outer catheter 4 within the cervical canal of thepatient. Distal end opening 272 can be configured to allow the evertingmembrane deliver the IUD (both not shown).

FIGS. 13C and 13D show another type of acorn tip 242 with lower profileanterior surface 274 with outer shoulders 270 that are reduced in theanterior portion of circumference of acorn tip 242. Lower profileanterior surface 274 provides the physician greater viewing angle of theexocervix when placing the everting catheter (not shown). The lowerprofile anterior surface can be used by the physician to gain bettervisualization of the exocervix while maintaining the functions of theacorn tip in regards to intubating the exocervix, gaining purchase, andproviding a stopping mechanism from inadvertent advancement of the outercatheter into the cervical canal. Alternative acorn tip 242 contains anintubation tip 268 on its distal end on the posterior surface tofacilitate initial device placement at the exocervix of the patient withramp 271 leading to shoulder 270. Dashed lines indicate through lumen276 with distal end opening 272.

Returning back to an alternative embodiment of everting catheter system2, FIG. 13E shows IUD 254 being advanced by everting membrane 6 inresponse to the advancement of inner catheter 8 within outer catheter 4using hydraulic energy supplied in extension tubing and stopcock 248. Inconjunction, pusher 264 can advance with everting membrane 6 with twostrands of IUD suture 252 exiting pusher hub 266.

FIG. 13F shows further advancement of IUD 254 with everting membrane 6and translation of inner catheter 8 within outer catheter 4. Roundedends 256 are exposed distal at the end of the everting membrane 6 as themembrane everts inside out and pulls the IUD forward.

FIG. 13G shows IUD 254 released from everting membrane 6 with IUD fullyin its natural state or “T” or “Y” shape. IUD suture 252 can be proximalto the IUD and runs through everting membrane 6, pusher 264, and innercatheter (not visible). To complete IUD release, pusher 264 advances IUD254 beyond the distal end of everting membrane 6.

FIGS. 13H and 13I illustrate alternative embodiments of the distal endof pusher 264. FIG. 13H shows distal end of pusher 264 with pusher cup278 with concave opening 280 to accept and hold the profile of theproximal end of IUD 254 (not shown). Pusher 264 can have through lumenwith central axis 282. Distal end pusher cup 278 facilitates thehandling and loading of IUD 254 within an everting catheter (not shown).

FIG. 13I shows an alternative form of distal end of pusher 264 withthrough lumen and central axis 282 and with a split tube opening 284 atthe distal end. Split tube opening 284 can be configured to open andaccept and hold the proximal end of IUD 254 (not shown). Distal endsplit tube opening 284 facilitates the handling and loading of IUD 254within an everting catheter (not shown).

FIGS. 14A and 14D illustrate the advancement of IUD 254 within aneverting membrane 6 from the collapsed state to the release of IUD 254and return to its natural state or “T” shape. FIG. 14A shows theeverting membrane 6 advancing through acorn tip 242 pulling IUD 254 in acollapsed, low profile state within an everting catheter system 2. Roundends 256 are compressed by the everting membrane 6 in response to thehydraulic energy supplied through extension tubing and stopcock (notvisible).

FIGS. 14B and 14C further illustrate the advancement of IUD 254 withinan everting membrane 6 within an everting catheter system 2. As IUD 254is pulled forward by the everting membrane, IUD 254 can return to itsnatural state or a “T” or “Y” shape. FIG. 14B shows the evertingmembrane 6 in a pressurized state via hydraulic energy. IUD suture 252can be contained within the distal end of pusher 264 within splitopening 284.

FIG. 14D illustrates another embodiment of everting catheter system 2 inwhich the hydraulic energy can be removed by a pressure source 286 viaextension tubing and stopcock 248. Once hydraulic energy is removed fromeverting catheter system 2, everting membrane 6 can no longer grip IUD254 and pusher 264 can advance the proximal end of IUD beyond the distalopening of everting membrane. Pressure source 286 an be an inflationdevice as shown or other devices such as a syringe, a syringe andcompliant tube, a pump, or a pressurized cannister or container.

FIG. 15A illustrates everting catheter system 2 equipped with aone-handed delivery mechanism. On the proximal end of everting cathetersystem 2, housing 288 can be configured with rolling wheel 290 and outercatheter release button 292. At the distal end, acorn tip 242 can bedesigned to engage the exocervix when placed in the patient for IUDdelivery and placement. IUD 254 can be visible within outer catheter 4.Extension tubing and stopcock 248 can be located on the posteriorportion of housing 288. Exiting the proximal portion of housing 288,pusher 264 and pusher hub 266 can be visible with IUD suture 252protruding the through lumen of pusher 264.

FIG. 15B demonstrates the one-handed operating mechanism of evertingcatheter system 2 using housing 288. The operator's thumb can be placedon rolling wheel 290 with outer catheter release button 292 in closeproximity. IUD 254 can be visible within outer catheter 4 and pusher 264with pusher hub 266 can be visible exiting the proximal portion of thehousing.

FIG. 15C shows a top view of the one-handed mechanism of evertingcatheter system 2 in which the inner catheter 8 can be visible inhousing 288. Also visible are inner catheter hub 246 with pusher 264protruding from the proximal portion of the inner catheter hub. IUDsuture 252 can be visible protruding from the proximal opening of pusherhub 266. Also visible within housing 288 can be pusher stop 294 and gearwheel housing 296 under the thumb of the operator.

FIG. 15D illustrates further in a top view the one-handed operation ofeverting catheter system 2 during the advancement of everting membrane 6puling IUD 254 through acorn tip 242. Rolling wheel 290 (partiallyvisible under the thumb of the operator) can be used to advance innercatheter 8 which allows the everting membrane to advance. Advancement ofthe everting membrane 6 can be limited when inner catheter hub 246reaches gear wheel housing 296. As the inner catheter 8 can be advancedinto the outer catheter 4, inner catheter hub 246 reaches gear wheelhousing 296 and advances pusher 264 until pusher hub 266 mechanicallyengages pusher stop 294. In operation, the operator will actuate outercatheter release button 292 that will allow the outer catheter 4 andattached everting membrane 6 to retract while pusher 264 maintains inplace in relation to housing 288 with pusher stop 294. The distal end ofpusher 264 thereby advances IUD 254 out of the distal end of evertingmembrane 6 and releasing IUD 254 in the uterine cavity. In operation,the operator will remove the entire everting catheter system 2 andhaving the IUD suture 252 threading out of pusher 264.

FIGS. 16A to 16J illustrate another embodiment of everting cathetersystem 2 with handle 30. Protruding distal to handle 600 can be outercatheter 4 and protruding proximal to the handle can be pusher 264 withIUD sutures 252 exiting the pusher hub 266. On the anterior portion ofhandle 600 can be inner catheter button 298 and outer catheter releasebutton 292. Protruding on the posterior portion of handle 600 can beextension tubing and stopcock 248 (partially visible).

FIG. 16B shows inner catheter button 298 being advanced within housingslot 308 on the anterior surface of housing 288. Inner catheter button298 is attached to the proximal end of inner catheter (not shown) andits advancement translates the inner catheter and everting membrane todeliver an IUD (not shown). In operation, inner catheter button 298advances until it engages outer catheter release button 292 also on theanterior surface of housing 288.

FIG. 16C shows the retraction of outer catheter release button 292 whichperforms the release of the IUD from the everting catheter (not shown).

FIG. 16D provides information on how housing 288 works with evertingcatheter system 2 to perform the advancement and release of the IUD (notshown). In FIG. 16D, the anterior portion of housing 288 is removedshowing the interior portions of the everting catheter system 2including inner catheter hub 246. Alternatively, inner catheter hub 246can be eliminated by inner catheter button 298 or have both devices asshown. Also visible is pusher 264 and pusher hub 266 with IUD sutures252 exiting the proximal portion of the pusher hub. Outer catheterrelease button 292 and inner catheter button 298 is also visible and atthis position, the advancement of the everting membrane (not shown) iscomplete. Contained within the posterior portion of housing 288 areinflation tubing slot 300 and pusher engagement tabs 302 which isconfigured to mechanically hold pusher hub 266 at the completion of theeversion step. Also visible are housing holes 304 that are designed tosnap the anterior and posterior sections of housing 288.

FIG. 16E shows a cut-away view of the proximal portion of Y-fitting 244with inner catheter 8 exiting the proximal of the Y-fitting. Extensiontubing and stopcock 248 (stopcock not shown) is exiting posteriorly fromY-fitting 244 and through housing 288 through inflation tubing slot 300.Outer tubing release button 292 is mechanically attached to Y-fitting244 and can be retracted in housing 288 along inflation tubing slot 300.

FIG. 16F shows the inflation tubing slot 300 on the posterior surface ofhousing 288 in another cut-away view. Extension tubing and stopcock 248(stopcock not shown) is visible in inflation tubing slot 300.

FIG. 16G shows a cut-away view of the proximal portion of housing 288and proximal hole 306. Cut away view of pusher 264 is visible exitingfrom the proximal portion of inner catheter hub 246. The internal trackof the pusher engagement tabs 302 that progressively gets narrower as itextends from the proximal portion of housing 288 to the distal portionis visible on the internal posterior surface of housing 288. Pusher hub266 can have a conical or tapered profile on its distal portion totravel through the pusher engagement tabs 302. The flat proximal portionof pusher hub 266 can serve as a mechanical detent in the proximaldirection once the pusher hub 266 extends beyond the pusher engagementtabs 302.

FIG. 16H shows the initial step of IUD delivery and placement withanother cut-away view of the right-hand side of housing 288 with outercatheter 4 distal to Y-fitting 244 and attached to outer catheterrelease button 292. Also, on the anterior surface of the housing and inhousing slot 308 is inner catheter button 298. Exiting proximal to innercatheter 8 and inner catheter button is pusher 264. Attached to theproximal end of pusher 264 is the pusher hub 266 with through lumen forIUD sutures 252.

FIG. 16I shows in the same cut away view the range of advancement ofinner catheter button 298 during the eversion step with evertingcatheter system 2 hydraulically pressurized through extension tubing andstopcock 248 (stopcock not shown). This embodiment shows an advancementof the inner catheter 8 within outer catheter 4 of 12.6 cm. Thisdistance of advancement corresponds to an insertion depth within theuterine cavity of 6.3 cm. Other lengths of advancement are possible from3 cm to 24 cm. In addition, the depth of insertion can be under thephysician's control by stopping the eversion step at any point duringthe process.

FIG. 16J shows the release step of the IUD delivery process witheverting catheter system 2 in which outer catheter release button 292 isretracted bringing pusher 264 through inner catheter 8 to advance theIUD (not shown) through the everting membrane (not shown).

FIGS. 17A to 17I illustrate further embodiments of an everting catheterthat delivers an IUD. FIG. 17A shows everting catheter system 2 withhousing 288 with pusher 264 and pusher luer hub 310 exiting proximal tothe housing. Pusher luer hub 310 is configured to accept a syringe 74 orother irrigation source to provide fluid, saline, contrast media,sonographic media, drugs or therapeutic agents, or a gas or air throughthe central lumen of everting catheter system 2. Irrigation fluid ormedia can facilitate visual identification of the exocervix or theuterine cavity with ultrasonography or fluoroscopy.

FIG. 17B shows everting catheter system 2 at the initial stage of theeversion process with anterior portion of housing 288 removed foridentification of internal parts and mechanisms.

FIG. 17C shows everting catheter system 2 with hydraulic energy issupplied through extension tubing and stopcock 248. Inner catheterbutton 298 is advanced to translate inner catheter 8 within outercatheter 4. Everting membrane 6 exits distal to acorn tip 242 and pullsIUD (not shown) and pusher 264 through the central lumen of evertingcatheter system 2. Pusher luer hub 310 is translated through proximalhole 306 of housing 288 and into the track of pusher engagement tabs302.

FIG. 17D shows the next step of the eversion process with inner catheterbutton 298 engaging outer catheter release button 292 and pusher luerhub 310 reaching mechanical detent of pusher engagement tabs 302.

FIG. 17E shows the next step in the IUD delivery process with syringe 74connected to extension tubing and stopcock 248 to draw negative pressurewithin everting catheter system 2. Negative pressure withdraws thehydraulic energy in the everting membrane 6.

FIG. 17F shows the next step in the IUD delivery process with outercatheter release button 292 retracted and thereby retracting the outercatheter 4, everting membrane 6, and inner catheter 8 while maintainingthe position of the pusher 264 relative to the housing 288. Pusherengagement tabs 302 prevent the pusher luer hub 310 from retracting andthereby maintaining the position relative to the housing 288.

FIG. 17G shows a close-up photograph of the distal end of the evertingmembrane 6 with hydraulic energy removed from everting catheter system 2and with distal end of pusher 264 extending beyond the distal opening ofthe everting membrane 6. Split tube opening 284 is at the distal end ofpusher 264 and illustrates that the distal end of pusher 264 can exiteverting membrane 6.

FIG. 17H shows an alternative type of syringe 74 with plunger spring 314on plunger 76. Engagement button 312 can translate within syringehousing 208 to lock onto ridges 316 on multiple locations on plunger 76.When depressed, engagement button 312 can lock plunger spring 314 in acompressed condition.

FIG. 17I shows syringe 74 with engagement button 312 released allowingplunger spring 314 to expand and retract plunger 76 back to providenegative pressure within syringe 74 and an everting catheter system 2(not shown).

FIGS. 18A through 18C illustrate another embodiment of everting cathetersystem 2 that automatically provides negative pressure to removehydraulic energy in the everting catheter at the step of releasing theIUD (not shown) during the delivery and placement procedure. FIG. 18Ashows everting catheter system 2 with housing 288 and syringe 74 mountedor attached to the bottom posterior surface of the housing. Syringe 74can have plunger spring 314 compressed and engagement button 312 lockedinto syringe housing 208. Syringe 74 is connected via inflation tubing318 as a conduit for the hydraulic energy within everting cathetersystem 2.

FIG. 18B shows the advancement of inner catheter button 298 in housingslot 308. Advancement of inner catheter button 298 translates innercatheter (not shown) within outer catheter 4 and advancing evertingmembrane and IUD (both not shown).

FIG. 18C shows the next step in the IUD delivery and placement process.The depression of outer catheter release button 292 forces engagementbutton 312 to release plunger spring 314 and plunger 76 to createnegative pressure in the everting catheter system 2 via inflation tubing318. At this point the outer catheter release button can be retractedback along housing slot 308 to retract the outer catheter 4, evertingmembrane and inner catheter (not shown) while maintaining the positionof pusher (not shown) and releasing the IUD from the everting membrane(both not shown).

FIG. 19A illustrates an everting catheter system 2 for delivering an IUDin the inverted state. IUD 254 can be loaded in a collapsed conditionwithin balloon membrane (not visible) and inner catheter 8. Innercatheter 8 can be within outer catheter 4. At the distal end of outercatheter 4, moveable flange can be a marker for insertion depth withindicia 402. The proximal end of outer catheter 4 there is a t-fitting244 for pressurization of the everting balloon with x-ring valve (notshown) for the translation of inner catheter 8. Inner catheter 8 hasproximal hub 246 that can be a luer connector, knob, or handle for themanipulation of inner catheter. Within the central lumen of innercatheter 8 is pusher 264 with lumen for IUD suture(s) 252.Pressurization of everting catheter system 2 can be performed by syringe410 and syringe plunger 409 that can be connected by the user orphysician to connector 413 that can be connected to compliant tube 412.Pinch clamp 411 can be used by the user or physician to close complianttube 412 to maintain pressure within the everting balloon. Oncepressurized, syringe 410 can be disconnected and removed from theeverting catheter system 2 prior to insertion within the patient.

FIGS. 19B to 19D are close-up views of different sections of evertingcatheter system 2. FIG. 19B is a close-up view of the distal end ofouter catheter 4 with the initial portion of everting balloon 6 visibleexiting the distal end outer catheter 4. The distal end opening of outercatheter 4 have an acorn tip or no acorn tip and a smooth, rounded, lowprofile distal tip. The distal end can have indicia 402 which denote 7cm, 8 cm, 9 cm, and 10 cm markings for example, for showing the user(e.g., physician) an indication of insertion depth. Moveable flange 401can be placed by the user (e.g., physician) to provide a visible andtactile indicator for insertion depth. Visible within outer catheter 4can be IUD 254 in a collapsed, loaded, low profile state within theeverting balloon and inner catheter (not visible).

FIG. 19C is a close-up view of the pressurization system for evertingcatheter system 2. Pressurization of the everting catheter 2 can beperformed by syringe 410 filled with saline, sterile water, air, or aninert gas, or combination of gases and fluid media. Depression ofsyringe plunger 409 by the user or physician supplies hydraulic energyto the everting balloon. Syringe 409 can have a volume of 1 cc, 3 cc, 5cc, or 10 cc, for example, 3 cc as shown. Other volumes are possible.Pressurization of the everting catheter system 2 can distend complianttube 412. Compliant tube 412 can be made from silicone and/or otherelastomeric materials, such as polyurethane, rubber, and TPE, orcombinations thereof. Compliant tube 412 can maintain a near constantpressure within everting catheter system 2 during inversion andeversion. Compliant tube 412 can provide a mitigation from the user orphysician inadvertently putting in too much pressure within the evertingcatheter system 2 since the silicone tube can continue to distend inresponse to the added hydraulic pressure. Pressurization amount can 1 to4 atmospheres with 2 atmospheres as a nominal level. The amount ofcompliance within the silicone tube can depend upon the durometer of thematerial, the wall thickness of the tube, and the length of the tubeavailable for distension. As shown for example, compliant tube 412 canbe silicone with a durometer of 50 A, 6 cm in length, with an outerdiameter of 4.75 mm and wall thickness of 1 mm. The pressurizationsystem can be closed by the user with pinch clamp 411, for example toclose the internal lumen of compliant tube 412 once pressurized bysyringe 410. Other tubing closure devices can be used, such asstopcocks, gate valves, roller clamps, or combinations thereof. Aone-way check valve or a luer-activated valve can be on complaint tube412 instead of or in combination with connector 413 to allow for one-waypressurization without requiring the user to actuate a closure device toclose and maintain pressure within compliant tube 412 and evertingcatheter system 2. Hydraulic pressure supplied by syringe 410 andsyringe plunger 409 can be in fluid communication with everting cathetersystem 2 through t-fitting 244 with x-ring valve (not shown) maintainingpressure during eversion of balloon membrane and the translation ofinner catheter 8 within outer catheter 4. Inner catheter 8 can be madefrom nylon, Pebax, polypropylene, polyethylene, or combinations thereof.Inner catheter 8 can extend from the distal end of the fully evertedballoon to the proximal end of t-fitting 244 with an outer diameter of 4mm and an inner diameter of 3 mm.

FIG. 19D is a close-up view of the proximal portion of everting cathetersystem 2 and illustrates inner catheter 8 with proximal connector hub246 with central through hole. Within the central through hole can bepusher 264 with pusher hub 266 with central through hole with IUDsutures 252. Proximal connector hub 246 and pusher hub 266 can be luerconnectors to allow for the connection of syringes or tubing for theinjection of fluid, saline, or gas media for distention of the uterinecavity for ultrasound, fluoroscopic, or endoscopic visualization.Proximal connector hub 246 and pusher hub 266 can be handles or knobsfor manipulation of the catheters by the user or physician. Pusher 264can be made from nylon, Pebax, polypropylene, polyethylene, orcombinations thereof. Pusher 264 tubing can have an outer diameter of 2mm and inner diameter of 1.25 mm and a length that approximates theentire length of everting catheter system 2, for example, to allow theuser or physician to expel the IUD from inner catheter 8 duringplacement within the uterine cavity.

FIG. 20A illustrates the everting catheter system 2 after full eversionof the balloon in the process of delivering an IUD. IUD 254 can be in acollapsed, loader state within inner catheter 8 and everting balloon 6.Outer catheter 4 can contain indicia markings 402 and depth insertionmarker flange 401. Outer catheter 4 can be connected to t-fitting 244with x-ring valve (not shown) and can be connected to compliant tube 412with luer connector 413 and tubing pinch clamp 411 for hydraulicpressurization of everting catheter system 2. Immediately proximal tot-fitting 244 can be proximal connector hub 248 denoting full eversionof the everting balloon and full translation of inner catheter (notvisible). Proximal to the proximal connector hub 248 is pusher 264 andpusher hub 266. Proximal to pusher hub 266 can be IUD sutures 252 seenbeyond the central lumen of the tubing.

FIG. 20B is a close-up view of the distal end of the everting cathetersystem 2 with fully everted balloon 6 and IUD 254. Distal end of innercatheter (not visible) can be connected to everting balloon 6 androunded distal ends 256 of IUD 254 can be immediately distal to thefully everted balloon 6. Visible through the everted balloon 6 and innercatheter can be portions of IUD 254 including copper wire 271, IUD stemhole 272, suture knot 273 and IUD sutures (not visible). Evertingballoon 6 can be connected to outer catheter 4 with indicia markings402. For example, everting balloon 6 can be 6 cm long to traverse thelength of the cervix and which can be 3.5 cm in length from theexocervix to the internal cervical os. Different lengths of evertingballoon 6 can be used to approximate the uterine lengths of differentpatients. Everting balloon can, for example, have an outer diameter of 4mm in the pressurized state of 2 atmospheres and a wall thickness of0.0015″ thousandths of an inch. Everting balloon can be made fromirradiated polyolefin, polyethylene, Pebax, polyurethane, otherbiocompatible materials that can create a hydraulic everting balloon, orcombinations thereof.

Distal end of inner catheter (not visible) can have an internal diameterthat, for example, can allow for the collapsed IUD to fit within thetubing. For example, an internal diameter of 3 mm can allow thecollapsed IUD to fit within the tubing but keep the rounded distal ends256 protruding distal to the inner catheter (not visible) and theeverting balloon 6. Distal end of pusher (not visible) can be justproximal to IUD stem hole 272 and suture knot 273. Distal end opening ofeverting balloon 6 can be connected to the distal end of the innercatheter (not visible). When inverted and pressurized, everting balloon6 can collapse IUD 254 in a lower profile state that facilitatesadvancement through the cervical canal and into the uterine cavity. Wheninverted and pressurized, everting balloon 6 can collapse and compressthe rounded distal ends 256 together to a low profile, for example, foradvancement through the everting catheter system 2, the distal endopening of the outer catheter 4, and the cervical canal and into theuterine cavity.

FIG. 20C is a close-up view of the proximal portion of the evertingcatheter system 2 after full eversion in the process of delivering anIUD 254. Outer catheter 4 can be connected to t-fitting 244 with x-ring(not visible) and is fluidly coupled to compliant tube 412 with tubingpinch clamp 411 shown in the closed condition with hydraulicpressurization within the everting catheter system 2. Proximal connectorhub 248 can be seen immediately proximal to t-fitting 244, for example,denoting full eversion of the everting balloon (not shown) and fulltranslation of the inner catheter (not visible). Within proximalconnector hub 248 can be pusher 264 with pusher hub 266 on its proximalend with IUD sutures 252 seen exiting through the central lumen ofpusher 264.

FIGS. 21A to 21C illustrate the process of delivering an IUD within asimulated uterine cavity model 500 (standing in for a patient's uterinecavity and other respective anatomy for illustrative purposes) withmetric scale 510 provided for reference. FIG. 21A illustrates theplacement of IUD 254 within simulated uterine cavity model 500 withfundal portion 501 which simulates the cranial apex of the uterinecavity, and cornual regions 502 (denoting the patient's right fallopiantube os) and 503 (denoting the patient's left fallopian tube os).Simulated uterine cavity model can contain lower uterine segment 504with simulated cervical canal 505 and simulated exocervix 506. Evertingcatheter system 2 can have everted balloon 6 fully everted with roundeddistal ends 256 of IUD 254 approximating the fundus 501 of the uterinecavity and distal to the everted balloon 6. Pusher 264 can be proximalto IUD 254. Flange 401 can abut the exocervix 506 with an insertiondepth of approximately 9 cm, for example.

FIG. 21B illustrates a next (e.g., intermediate) step in the process ofIUD placement with everting catheter system 2. Everting catheter system2 can be retracted 1.5 cm as seen by flange 401 now being a distance,for example, of 1.5 cm from exocervix 506. In combination, IUD 254 canbe expelled from the distal end of everting balloon 6 with pusher 264and retraction of everting catheter system 2. IUD 254 can have roundeddistal ends 256 extending outward towards cornual regions 502 and 503.

FIG. 21C illustrates a next (e.g., final) step of IUD 254 placement withthe everting catheter system (not shown) that can be completely removedfrom simulated uterine cavity model 500. Rounded distal ends 256 canremain in the cornual regions 502 and 503. IUD sutures 252 can bevisible exiting the exocervix 506. The user or physician can trim theexcess length of IUD sutures 252 depending upon the amount of excess IUDsuture or type of IUD.

FIGS. 22A to 22E illustrate a packaging configuration for the transitand loading of the everting catheter system 2 for delivering an IUD.Everting catheter system 2 can be placed onto pouch card 600 in thefully everted position with IUD 254 at the distal end of the evertingballoon (not visible). Pouch card 600 and everting catheter system 2 canbe placed into a sealed pouch (not shown) for sterilization, shipping,and eventual usage by a physician. Pouch card 600 can be made from cleanlaminated paper card stock, PETG, polypropylene, polyvinyl chloride,PET, or combinations thereof. Affixed to pouch card 600 can beprotective tube 601 which can be, for example, 6.5 cm in length with anID of 4 mm. Protective tube 601 can be sized in length to fit over thefully everted balloon (not visible) and leave IUD 254 in the openconfiguration with rounded distal ends 256 beyond the distal end of theprotective tube 601. Protective tube 601 internal diameter can be sizedto allow a non-pressurized everting balloon (not visible) to slidethrough the central lumen. When everting balloon (not visible) ispressurized, everting balloon outer diameter can contact the internallumen of protective tube 601. Contacting the internal lumen whenpressurized can, for example, allow the user or physician to easilyretract the everting balloon and inner catheter for loading andpreparation for use. Protective tube 601 can be made from nylon but canbe made from polypropylene, PET, Pebax, and other tubing materials usedin medical device packaging. T-fitting 244 and proximal connector hub(not visible) can be held in place by pouch tabs 602 with inner catheter(not visible) fully translated into outer catheter 4. Pusher 264, pusherhub 266, and IUD sutures 252 can extend proximal to everting cathetersystem 2.

FIG. 22B is a close-up view of a variation of the distal portion ofpouch card 600 and protective tube 601 with everting balloon (notvisible) fully everted within protective tube 601. IUD 254 can be in anopen configuration and can be positioned at the distal end of evertingcatheter system 2 with IUD sutures (not visible in this view) runningthrough the entire length of the inner catheter and pusher of evertingcatheter system 2. Proximal end of protective tube 601 can be intubatedby the distal end of outer catheter 4.

FIG. 22C illustrates a step (e.g., unpacking, assembling, andpressurizing) in the preparation of everting catheter system 2. Pouch603 can be peeled back halfway to expose the proximal portion of pouchcard 600. The user or physician can connect syringe 410 to complianttube 412 with pinch clamp 411 in the open position. The compliant tubecan be rotated upwards or perpendicular to the surface or pouch card600. The everting catheter system can be pressurized with 3 cc ofsaline.

FIG. 22D shows the compliant tube 412 pressurized with pinch clamp 411can be in the closed position with syringe disconnected and removed fromluer connector 413. IUD sutures 252 can then pulled to retract IUD 254within the distal end of the inner catheter (not visible) withinprotective tube 601.

FIG. 22E is a close-up view of the distal portion of pouch card 600 withthe IUD 254 that can be in the collapsed and loaded configuration insidethe inner catheter (not visible) within protective tube 601. Theeverting balloon (not visible) can then be fully inverted with innercatheter (not visible) that can be fully translated back, for example,to remove the everting catheter system 2 from the protective tube 601and pouch 603 in preparation for insertion into the patient.

Any elements described herein as singular can be pluralized (i.e.,anything described as “one” can be more than one). Any species elementof a genus element can have the characteristics or elements of any otherspecies element of that genus. The media delivered herein can be any ofthe fluids (e.g., liquid, gas, or combinations thereof) describedherein. The patents and patent applications cited herein are allincorporated by reference herein in their entireties. Some elements maybe absent from individual figures for reasons of illustrative clarity.The above-described configurations, elements or complete assemblies andmethods and their elements for carrying out the disclosure, andvariations of aspects of the disclosure can be combined and modifiedwith each other in any combination. All devices, apparatuses, systems,and methods described herein can be used for medical (e.g., diagnostic,therapeutic or rehabilitative) or non-medical purposes.

U.S. Pat. No. 9,028,401, issued May 12, 2015; U.S. Pat. No. 9,101,391,issued Aug. 11, 2015; and U.S. Pat. No. 10,034,986, issued Jul. 31,2018; and U.S. Published Application Nos. 2019/0009058, published Jan.10, 2019; 2020/0206463, published Jul. 2, 2020; 2020/0297384, publishedSep. 24, 2020; and 2020/0023162, published Jan. 23, 2020 which are allincorporated by reference herein in their entireties.

Any elements described herein as singular can be pluralized (i.e.,anything described as “one” can be more than one). Any species elementof a genus element can have the characteristics or elements of any otherspecies element of that genus. “Dilation” and “dilatation” are usedinterchangeably herein. The media 155 delivered herein can be any of thefluids (e.g., liquid, gas, or combinations thereof) described herein.The patents and patent applications cited herein are all incorporated byreference herein in their entireties. Some elements may be absent fromindividual figures for reasons of illustrative clarity. Theabove-described configurations, elements or complete assemblies andmethods and their elements for carrying out the disclosure, andvariations of aspects of the disclosure can be combined and modifiedwith each other in any combination. All devices, apparatuses, systems,and methods described herein can be used for medical (e.g., diagnostic,therapeutic or rehabilitative) or non-medical purposes.

We claim:
 1. A system for delivering a device into the reproductive tract of a female comprising: a first catheter having a lumen and a distal lumen port, wherein the first catheter has a retracted configuration and an extended configuration; an everting balloon attached to the first catheter, wherein at least a length of the everting balloon extends past a distal end of the first catheter when the first catheter is in the extended configuration; a second catheter slidably located in the first catheter; an IUD in the second catheter; and a third catheter radially outside of the first catheter.
 2. The system of claim 1, wherein the length of the everting balloon that extends past the distal end of the first catheter comprises a check valve when the first catheter is in the extended configuration.
 3. The system of claim 1, wherein the second catheter is configured to deliver the IUD.
 4. The system of claim 1, wherein the system is configured to release the IUD concurrent with delivering negative pressure within the everting balloon.
 5. The system of claim 1, further comprising a pusher in the second catheter.
 6. The system of claim 5, wherein the pusher comprises a connection hub.
 7. The system of claim 5, wherein the pusher comprises an irrigation mechanism.
 8. The system of claim 1, further comprising an irrigant, wherein the system is configured to deliver the irrigant through the second catheter concurrent with releasing the IUD from the second catheter.
 9. The system of claim 1, further comprising an irrigation mechanism configured to deliver an irrigant through the second catheter.
 10. The system of claim 1, wherein the system is configured such that the pusher extends the IUD as the IUD is released from the second catheter concurrent with negative pressure being delivered within the everting balloon.
 11. A system for delivering a device into the reproductive tract of a female comprising: a first catheter having a lumen and a distal lumen port, wherein the first catheter has a retracted configuration and an extended configuration; an everting balloon attached to the first catheter, wherein at least a length of the everting balloon extends past a distal end of the first catheter when the first catheter is in the extended configuration; an IUD radially inside of the first catheter; and a third catheter radially outside of the first catheter. wherein the everting balloon is attached at a first end of the everting balloon to the third catheter, and wherein the everting balloon is attached at a second end of the everting balloon to the first catheter.
 12. The system of claim 11, further comprising a second catheter in the first catheter.
 13. The system of claim 12, further comprising a pusher in the second catheter.
 14. The system of claim 13, wherein the pusher comprises a connection hub.
 15. The system of claim 13, wherein the pusher comprises an irrigation mechanism.
 16. The system of claim 12, further comprising an irrigant, wherein the system is configured to deliver the irrigant through the second catheter concurrent with releasing the IUD from the second catheter.
 17. The system of claim 12, further comprising an irrigation mechanism configured to deliver an irrigant through the second catheter.
 18. The system of claim 12, wherein the system is configured such that the pusher extends the IUD as the IUD is released from the second catheter concurrent with negative pressure being delivered within the everting balloon.
 19. The system of claim 11, wherein the system is configured to release the IUD concurrent with delivering negative pressure within the everting balloon.
 20. The system of claim 11, wherein the length of the everting balloon that extends past the distal end of the first catheter comprises a check valve when the first catheter is in the extended configuration. 